Purpose of the Job: Responsible for management of quality systems and related standard operating practices. To ensure that the company Quality Manual and Quality Management System is effectively implemented into all aspects of the manufacturing process.
- Management, training, coaching and development of department’s staff
- Ensuring GMP compliance with regard to regulatory, customer and in-house requirements
- Driving best GMP quality standards across the business to all employees at all levels.
- Lead and facilitate the internal and external audit/ inspection programme for the plant which includes Corporate, Customer and regulatory inspections (MCC, TGA, EU)
- Overseeing the handling of product failures and anomalies - Investigation into root causes, effective implementation of corrective/preventive actions as well as recording and trending of data
- Control and review of all the systems of the Quality Management system, e.g. Deviations, CAPAs, Document Control, Risk Assessment and Change Control
- Establishing quality metrics, data collection, trending and analysis of KPI’s
- Compilation of Document Audits and Annual Management review for ISO 9001 certification.
- Involvement with project decisions which may affect the quality of the product
- Overseeing the Complaints Handling Process
- Lead the Vendor Management programme
- Overseeing and co-ordination of Product Recalls
- Managing the overall PQR (product quality review) process in accordance with GMP requirements.
- Reviewing and approving Validation/Qualification protocols and reports, including associated risk assessments and deviations
- Leads the Documentation Management process which includes the reviewing and approving of SOPs
- Managing and driving the self-inspection programme
- Able to work unsupervised
- Accurate with attention to detail and ability to identify risk
- Able to function effectively under pressure
- Strongly motivated by challenge and ability to work well as part of a team
- Perseverance and someone who is proactive
- Quality mind-set, always looking for improvement and best practice
- Takes full ownership of Quality Issues and sees them through to completion
- Relevant diploma / degree in Pharmacy, Science, Microbiology, Chemistry or Quality
- Profound knowledge of GMP regulatory requirements and ISO9001 standards
- Demonstrated ability of driving GMP compliance at all levels in a large organisation
- 5 to 10 years relevant pharmaceutical/ sterile manufacturing experience
- Experience / strong interest in product problem solving and continuous improvement
- Management experience within a quality function