5 Other Medical jobs in Midrand on Job Mail

Key Outputs:

• Assist with external audits were necessary; compile reports and follow-up on CAPA
• Participate in risk assessments on QMS and departmental processes to assess risk and identify mitigating actions and controls
• Conduct root cause investigations into incidents and deviations identifying root cause and CAPA
• Participate in Quality Management Reviews to identify trends in QMS processes and implement CAPAs to address any deficiencies
• Review and approve Master Batch Documents for compliance in line with the dossier
• Review Annual Product Quality Review reports and initiate CAPA’s from the recommendation of these reviews
• Compile, review and approve QMS SOP’s ensuring compliance to the SAHPRA cGMP Guidelines
• Train and implement the QMS SOP’s ensuring understanding by the relevant staff
• Review, track and follow through on change controls, deviations and assess the impact of the change and deviation on quality systems and processes
• Perform and track internal audits / self-inspections of departments as per schedule, compile reports and follow-up on corrective and preventive action
• Controlling and assigning expiry dates for finished products on the ERP system
• Review Packaging Material test reports
• Prepare monthly reports on the status of deviations, change controls, corrective and preventive action, risk assessments, and reprocesses
• Monitor compliance with cGMP requirements in the sterile plant
• Audit all sterile plant batch records for compliance and release
• Participate in validation programs, including media fill
• Review investigations arising from customer complaints, ensuring that complaints are thoroughly investigated, and effective corrective and preventative actions have been identified and implemented

Minimum Requirements:

• Bachelor Pharmacy Degree
• Registration with South African Pharmacy Council
• 1 years’ Sterile experience in aseptic manufacturing
• 2 years’ QA experience within a pharmaceutical manufacturing environment
• cGMP skills
• Computer Literacy: MS Office (proficient in Excel, Word, and Power Point)
• QMS and pharmaceutical knowledge
• Understand the requirements of the relevant Acts and regulations governing the pharmaceutical industry.

Competencies:

• Deciding and initiating action
• Leading and supervising
• Working with people
• Adhering to principles and values
• Presenting and communicating information
• Applying expertise and technology
• Learning and researching
• Planning and organizing
• Following instructions and procedures
• Adapting and responding to change
• Coping with pressure and setbacks

• You will provide clear direction, identify opportunities, and define the organizational structure of projects.

Key Performance Areas:

• Identify, quantify opportunities and issues through analysis of manufacturing site
• Oversee production processes ensuring that production is accurate and cost-effective
• Maintain production targets by ensuring that the required documents products are delivered daily
• Implementation of site efficiency reports and ensure alignment to site business improvement strategic objectives
• Measure, report and monitor efficiencies in the various departments and implement continuous improvements for efficiency improvements
• Conduct process improvement interventions.
• Ensure optimal value add to customer by delivering usable solutions to internal and external customers based on validated information
• Process improvement, such as cycle time improvement, usage of utilities, cost reduction, increase in yield, minimizing waste
• Identifying process inefficiencies and wastes of time, money, materials, and energy.
• Conducts studies in operations to maximize workflow and spatial utilization.
• Ensures facility efficiency and workplace safety
• Ensuring the translation of the business operational strategy into tactical project plans to deliver both tangible and intangible results (including performance improvement, cost reduction, lead time improvement, capability building and cultural change.
• Manage transformation improvement projects and build capability through training and coaching, provide leadership on how to solve problems and improve performance.

Minimum Requirements:

• Bachelor’s Degree/ B. Tech in Industrial Engineering
• Minimum of 3 years’ experience delivering on Performance Excellence and continuous improvement methods in a manufacturing environment (Lean, 6sigma, Shingo, TPM, TQM), demonstrating tangible business impact
• Experience in a pharmaceutical environment would be advantageous
• Experience in project management will be advantageous
• Ability to read, write, and interpret documents such as safety rules, standard operating procedures, maintenance instructions, and procedural manuals
• Able to change priorities and manage multiple projects simultaneously in a fast-paced environment
• Computer literate with prior experience with MS Office, Microsoft Project and general software technologies
• Previous project management experience and general management experience is necessary.

Core Competencies:

• Good Technical Skills
• Basic business acumen
• Customer Service Orientation
• Able to work shifts and Overtime
• G.M.P Compliance
• Safety Awareness
• Good Mechanical
• Problem solving skills
• Excellent Communicational skills

• Providing best practice day-to-day manufacturing pharmaceutical services to manage workflow, production and document procedure compliance so as to ensure safe and efficacious medicines are manufactured.

Qualifications and Experience:

• Pharm Degree
• Registered with South African Pharmacy Council
• Preferably 2-3 years’ experience in Pharmaceutical Production in a Manufacturing environment
• cGMP skills
• Computer Literacy – MS Office (proficient in Excel, Word and PowerPoint)

Outputs:

• Lead training on SOP, departmental inspection, and audits (both internal and external)
• Online and in line testing resulting in approval of batch documentation and Provisional releases
• Submission of full production manufacturing tickets and supporting documentation within 24 hours of batch completions
• Ability to identify, execute and prioritize work tasks/projects
• Excellent interpersonal, communication skills and collaborative
• Strong problem solving and troubleshooting capabilities
• Improve production efficiency and reduce overtime
• Proper documentation of manufactured pharmaceutical products
• Perform Line Openings and Closures in manufacturing lines
• Prepare weekly production scheduling of product
• Auditing batch documents for QA closure and release
• Assist in preparing Annual Product Quality Reviews
• Initiate, investigate and close off CAPAs and Non-Conformances.
• Ensure regulatory compliance Safety, Health and Environmental Standards.
• Oversight on manufacturing process including in-process checks
• Regulatory and document compliance
• Handling of non-conforming production, both inbound, WIP and produced batches
• Audits and continuous improvement capabilities
• Development of team’s technical capabilities
• Lead / champion change overs, line opening, line closing,
• Lead and be the chief accountable officer for GMP and micro compliance in the area on shift

We have a position available for a dynamic Personal Assistant in the Kyalami (Midrand) area. The successful candidate will be responsible for all administrative duties and assistance to Director.

Requirements:

• Matric / Grade 12
• 3- 5 years' experience as a Personal Assistant
• MS Office (Word and Excel) experience
• Pastel experience
• Valid drivers license and own reliable transport
• Must stay in a reasonable distance Kyalami (±10-15km)
• Adaptable, attention to detail and excellent administration skills
• Excellent communication skills (English - both written and spoken)
• Should preferably be able to start immediately or with a short notice period

Responsibilities (Not limited to):

• Administration
• Making travel arrangements
• Organising meetings and booking of meeting rooms / locations
• Assisting with presentations and reports
• Maintaining the filing and database systems

Please note only shortlisted candidates will be contacted. To apply please click on the "apply" button and you will be redirected to another site.