JOB PROFILE – Technical Manager: Operations

1. 1.    About the Department          

Department

The Supply Chain team is responsible for to identifying and implementing effective processes that will enable a robust supply chain ensuring high levels of availability to support the entire Value Chain.

1. 2.    Position Overview

Knowledge         Standards for GMP and Quality in Cosmetics

Regulations regarding product labelling in Cosmetics, Food or Pharma

Technical Specs in Cosmetics, Food or Pharma 

Knowledge of packaging and packaging technology in Cosmetics or Food

Knowledge of formulation and ingredients used in Cosmetics or Food

Effective and practiced use of Word, Excel, Outlook

Purpose

1. 3.    Job Requirements - Functional Duties and Responsibilities

Key Performance Indicators            Outcomes

ISO GMP and Quality StandardsTake overall responsibility for ISO 22716 GMP, Sedex SMETA and ISO 9002 for the company:

• Schedule and publish the programme to maintain certification on the above standards.
• Prepare annual budget for authorisation and monthly reviews for the cost of certification.
• Liaise with certifying bodies and coordinate activities required for certification.
• Keep up to date on amendments or changes to Standards.
• Understanding and implementing the requirements for the standards via Internal Auditing and Gap Management which is the backbone of obtaining and maintaining certification.
• Completing, maintaining and version controlling the ISO Library on the K Drive. POL019-0 Document Control Policy and Procedure

ü Completing: Ensuring required documents are produced including SOPs, Work Instructions, Policies and Record Items such as forms logs

ü Maintaining: Ensuring that all changes made to procedures are managed in an integrated manner and that the total impact of the change is managed across relevant SOPs, WIs, Documents

ü Maintaining the Library indices

ü Version Control: Recording changes on the Change Log on the K Drive, and issuing Change Notifications to relevant parties detailing changes

• Completing, maintaining and version controlling the physical Master Library with signed originals in alignment with the electronic Library.
• Assuring the consistency, quality, completeness and

Agree and communicate the Quality Goals and Quality Management System of the company:

• Publish an agreed Quality Goals per annum and report on progress monthly.
• Ensure that integration of all policies, procedures and documents within the Company by:

ü Assuring the integrity and security of the K Drive ISO Library

ü Assuring the conformance to standard of all documents in the ISO Library

ü Assuring that full integration of all policies, procedures and documents so that they do not contradict each other and are sufficient to control the quality of the process or action.

• Ensure that all Procedures, Work Instructions and Documents that make up the Quality Management System and cover the work of the Technical Department are in place, up to standard and up to date in accordance with current and best practice.

Ensure that the following are being recorded logged- Out of Specification (OOS), Deviations to Process and Concessions:

QC-L-1.1.2-0 OOS and Deviation Log

• Ensure that each QO is training and monitoring their staff in the complete and accurate logging of OOS and Deviations on this Log.
• Ensure that each QO is correctly assigning ownership and agreeing responsibility for action with the owner for all logs by their Inspectors.
• Ensure that each QO is assigning target completion date with the owner and entering this on the Log

QA-L-0.0.1-0 Concession Log

• Ensure that each QO is complying with the relevant procedures when logging Concessions
• Ensure that each QO is fully completing the required information in the Concession Log

Ensure that logged- Out of Specification (OOS), Deviations to Process and Concessions are investigated, resolved and closed:

• Ensure that each QO is following up on person responsible for action completing their action taken on the Log.
• Ensure that each QO is completing the Quality Review and updating the Status on the Log.
• Ensure that each QO is carrying out root cause and prevention where appropriate and that trends and repeats are being systematically eliminated.
• Ensure that each QO is closing out logged items on time and when appropriate and that any unresolved issues or repeat issues are being raised early and correctly.
• Set up a monthly schedule with each QO to review the above for their area. Include a rating achieved for the year in their performance review score.

Report on Out of Specification (OOS), Deviations to Process and Concessions:

• Provide dashboard data and overview narrative on OOS, Deviations and Concessions in Monthly Report.

Regulatory Compliance on Product        Keep up to date on relevant regulatory issues and ensure company compliance with current and evolving regulation pertaining to:

• cosmetic labelling and documentation
• banned raw materials or packaging materials (EU regulations, CTFA Cosmetic Compendium especially Annex ii, iii, iv, vi, vii and, where relevant, BWC. Advertising Standards of SA)

Maintain up-to-date knowledge of current regulations and relevant technical product information.

Communicate with the NPD and R&D teams:

• Attend Project Meetings
• Provide input to the NPD product development process (new and reformulated products) to ensure regulatory and business requirements are met (product claims, ingredient guidelines, allergens, product name etc.).
• Advise on current and emerging cosmetic labelling requirements

Responsible for accurate information on product labels or printed bottles, including INCI’s.

• Responsible for the overall label or information accuracy on the product pack, including the correct formatting, warnings and ingredient statements.
• Check and sign off finished artwork proofs and standards.

Department Management and Reporting             Hold daily meetings with the Quality Officers to:

• Get updates on Daily and Monthly Plan and Progress
• Discuss other team news such as illness, company notices or instructions, training etc.

Resolve queries or concerns raised by the QOs by:

• Inviting and using questions or queries to make sure that the teams are on track and the QO improves their own critical thinking and problem-solving skills over time. Providing clear resolution to problems and challenges where needed.
• Promptly addressing intra-departmental conflicts or issues that may affect quality and productivity of the Technical Team within the company.
• Addressing conflicts or issues unresolved by QO’s with all parties present and in a positive, fair and firm manner.

Train staff on the applicable HSE and Quality policies and procedures of the company and by:

• Providing all health and safety information, documented instruction and training to all team members whether permanent or temporary.
• Not permitting or requiring any employee to do any work, unless the necessary precautionary measures have been taken and training provided.
• Ensuring that all members of the department are trained on appropriate job-related procedures and are assessed and found competent at least once per annum.

Ensure adherence to the standard operating procedures of the department by:

• Ensuring that the department sets the standard for compliance to procedure as well as upholding it and insisting that QOs log and measure their own staff’s deviations from standard procedure.
• Observing the work being carried out by the Department at least once a week and addressing any training or other issues noted with the QO’s.
• Having an independent internal audit of the department and its activities carried out at least once a year.

Conduct periodic checks to review the accuracy of paperwork, logs and physical standards and retains by:

• Setting up a quarterly schedule with each QO to review the above, including the rating achieved for the year in their performance review score.

Ensure positive and consistent discipline in the team by:

• Timeously and correctly applying the positive corrections required by the company Disciplinary policies and procedures as appropriate.
• Carrying out annual performance reviews with all QOs and ensuring that they do the same for their team members.
• Not allowing behavioural or performance deficits to slide and persist until they become chronic or serious through inattention.
• Ensuring that all discipline is provided in a positive, fair, compliant and even-handed manner

Motivate staff to continuously improve by:

• Catching team members doing things right – not just doing things wrong - and commenting positively on this immediately.
• Using a positive and energetic tone and approach with the team when there is a heavy workload and pressure.
• Acknowledging the effort and results achieved especially when it has been done under pressure.
• Offering support and coaching to get to the finish line as a team.
• Encouraging teamwork and achieving team goals by acknowledging good teamwork contributions.
• Boosting confidence and a sense of pride within the team by giving feedback on improvements made, goals attained, standards kept, and changes implemented.

Provide a Monthly Technical Report:

• Having the QO’s record key data within their areas and provide a monthly summary in a template format.
• Consolidate all data for the report and write a narrative summarising:

ü  Trends

ü  Issues

ü  Achievements

Customer Audits and CAPA Management             Take overall responsibility for Customer Audits of the company:

• Save all Customer Audit Standards on the K Drive and keep up to date on amendments or changes.
• Publish an annual calendar of existing customer audits by month.
• Act as the single point of liaison for scheduling customer audits – existing and new potential customers.
• Ensure all the necessary parties are advised well in advance prior to audit booking time in diaries.
• Ensure that reminders are sent out with reminders on any outstanding matters still outstanding from last audit by the customer.
• Convert Post Audit Non-Conformance Report into the Company standard for Non-Conformance, expanding corrections required down to task level where necessary and proposing ownership and deadlines for consultation and agreement.
• Get approval from MD on Action Plan and Deadlines.
• Prioritise major non-conformances and ensure that any customer deadlines for closing a gap to avoid shutdown are communicated.
• Schedule Non-Conformance Meetings, updating progress on the Report and issuing updates regularly internally and to the customer.
• Where necessary and appropriate carry out and report on root causes and prevention.
• Provide dashboard data and overview narrative on Customer Audits, Reports and CAPA in Monthly Report.

Customer and Product Complaints         Keep up to date on relevant Regulatory and Customer standards pertaining to product and consumer safety and satisfaction.

Take overall responsibility for Customer/Product Complaints and Product Recalls for the company:

• Act as the single point of liaison and reporting for managing customer and product complaints and product recalls.
• Ensure that the various parties carry out all the activities and responsibilities in accordance with

ü QA006 Product Complaint Procedure

ü QA007 Product Recall Procedure

ü Consumer Protection Act 68 of 2008

• Arrange a Dummy Recall once per annum for each Key Customer:

ü Liaise with Customer and ensure up to date with their procedure and reporting requirements.

ü Liaise with Customer and arrange date and terms of reference for Dummy Recall.

ü Co-ordinate the internal activities to carry out Dummy Recall and record the time taken and the activities carried out for review internally and with Customer.

ü Ensure that any corrective or preventive actions needed and agreed are carried out and reported on so that the Dummy Recall can be closed out.

• Provide dashboard data and overview narrative on Customer/Product Complaints and Recalls in Monthly Report.

Product Information File, Product Specification and Final MOMSet up and maintain Product Information File or PIF per product as follows:

• Set up a Folder for every Product as follows:

ü  M Drive/Product Information File/Customer/F-Code

ü  Use the PIF template to create the sub folders

ü  Use the Lisam System and Programme where appropriate

ü  Populate the sub folders with the relevant documents from the following sources:

• Project Folder
• R&D where appropriate
• Emailed information where appropriate
• Arrange annual audit and ensure that any missing documents are obtained or located.
• The following outlines the accountability and responsibility for documents in the PIF:

External Lab Tests, Formulation and MOM 

• RDC is responsible for providing MOM, testing and external lab reports,
• Technical Manager is accountable to ensure that the documents are filed in the PIF

Stability & Compatibility Tests, Results and Reports

• Quality Officer (Raw and Mass) is responsible for carrying out and providing Stability and Compatibility tests and reports.
• Technical Manager is accountable to ensure that the documents are filed in the PIF

Packaging Tests, Results and Reports

• Quality Officer (Packaging and Finished Goods) is responsible for carrying out and providing Packaging Tests and Reports.
• Technical Manager is accountable to ensure that the documents are filed in the PIF

JADs and Component Specs

• Product Dev Manager is responsible for compiling and providing Component Specs, and JAD Form where required.
• Technical Manager is accountable to ensure that the documents are filed in the PIF

Technical Drawings, Artwork and Final BOM

• Product Dev Manager is responsible for obtaining and providing signed-off PDFs of the Technical Drawings, Artwork and Final BOM.
• Technical Manager is accountable to ensure that the documents are filed in the PIF
• Note technical drawings are only compulsory for primary packaging components.

Kick off the Product Specification by creating a Product Spec per product for all Project briefs received or created:

• Once the Lab has logged the Product Descriptions, and Lab Codes against the Project number, Open Product Spec Template and create a Product Spec per Product
• File on M Drive by Customer in Product Spec Folder.

Set up and maintain a Product Spec Document (Product Specification) in accordance with each Customer’s requirements as follows:

• Provide Product Spec on Formulation (Cover page plus page 1 of Spec) for Tender submission and Red Seal sign off by:

ü Providing paperwork to accompany physical formulation samples submitted to the customer for Tender.

ü Providing updated paperwork for any Lab rework of first submission formulation sample/s, required by customer.

ü Providing paperwork to accompany physical formulation samples submitted to the customer for Red Seal Sign off.

• Once Development has been completed in Phase 4, finalise the Product Specification and ensure regulatory compliance as follows:

ü Finalising and double checking the Ingredient and Packaging Information.

ü Liaising with R&D Lab and Product Development Manager regarding Claims both hard and soft, and claims testing. Ensuring that this is done in compliance with regulations and inputting on the Product Specification.

ü Liaising with R&D Lab and Product Development Manager regarding labelling “instructions for correct usage” and “instructions for storage” Inputting this on the Product Specification.

ü Inputting the following product labelling and regulatory information on the Product Specification:

• Allergens
• Warnings
• Cautions
• INCI Listing
• Input the following onto the Product Specification:

ü Shelf life

ü Supply chain storage instructions

ü Batch coding information

ü Finished product quality control testing and release protocols

ü Quality Assurance Inspection Flow

• Complete Attachments and Annexures to the Product Specification as appropriate

ü Inspection Flow Diagram (if requested by customer)

ü Finished Product Material Safety Data Sheet MSDS

Final PDF MOM (method of manufacture)

• RDC emails signed Manufacturing Instructions (MOMs) in PDF format after successful pilot of a new launch or a formulation change.
• Checks that MOM is complete and signed.
• Files the MOM on M Drive using the M Code as the main Name and adding suffix for new versions.
• Moves MOM which have been discontinued or have been replaced by a new version into the MOM Archive folder.

Conduct periodic audits to review and maintain the accuracy of PIFs and Product Specs.

Archive PIF’s and Product Specs for a minimum of 10 years

Raw Material Specifications and Standards

               Note: It is the responsibility of the RDC to source ingredients, raw materials and compounds that are:

• Available from reputable manufacturers or suppliers
• Supported by MSDS, technical analysis and testing data to demonstrate the safety and efficacy of the ingredient.
• Compliant with customer requirements, preferences
• Compliant with key regulatory bodies and statutes

Ensure that new R and B Codes comply with Regulations and with customer policies and preferences on ingredient usage (raw material). Also considers such items as:

• Animal Derived
• Bad Press
• Banned
• Any required conformance to BWC standards (Beauty Without Cruelty)

Attend regular meetings with reputable raw material suppliers set up by the R&D Chemist to ensure up to date knowledge of raw materials and technology.

Job Specific Skills:

• Upholds quality and regulatory standards fearlessly, ethically and consistently.
• Is focused, productive and comfortable to work at big picture and detail levels.
• Is thorough and meticulous to check and produce high quality work
• Is target focused to meet deadlines and is reliable in finishing tasks
• Manages tasks and people by being methodical and planning and prioritising well
• Communicates clearly. Managing, sharing and obtaining information internally and externally
• Creates strong and positive connections with stakeholders internally and externally