Job Description

Key Responsibilities:

• Coordinate and manage annual internal, external, and vendor audit programmes, ensuring effective planning, execution, and reporting.
• Oversee QMS systems and tools, ensuring risk assessments are conducted, changes are properly documented, and document/record control is maintained.
• Maintain, review, and report on QMS systems, processes, and procedures in line with QA objectives and regulatory requirements.
• Identify, track, and report on quality metrics, implementing continuous improvement initiatives where required.
• Lead, mentor, and manage a team of QA professionals, driving performance, professional development, and a quality-focused culture across the organisation.
• Represent the QA department in cross-functional initiatives and management meetings, and set annual quality objectives.
• Manage and enhance the SAP QM system, ensuring notifications are correctly created, workflows managed, and training provided.
• Draft and review User Requirements Specifications for system changes, supporting IT during implementations.
• Ensure QMS procedures are consistently implemented, reviewed, and followed, with ongoing training provided.
• Lead GMP audit activities, analysing trends, escalating issues where necessary, and ensuring effective audit reporting.
• Oversee the document management system (SAP DMS and SharePoint), ensuring compliance and operational continuity.
• Manage the change control system, ensuring GMP-related changes are properly evaluated, documented, implemented, and reviewed.
• Drive process risk assessments and mitigation strategies, maintaining risk registers and facilitating periodic reviews.
• Monitor retention samples and material status within the QMS to ensure GMP compliance.
• Stay up to date with regulatory guidelines and industry changes, ensuring internal alignment.
• Support QA contributions to regulatory submissions, SHE audits, and internal investigations.

Minimum Requirements:

• Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Biological or Pharmaceutical Sciences, or a related technical/scientific field.
• At least 5 years' experience in pharmaceutical manufacturing or pharmaceutical quality, with strong knowledge of facilities, equipment, laboratories, and Quality Management Systems.
• 2+ years' experience in supervising/leading teams.
• 2+ years' experience as an auditor of quality systems (ISO9001, ISO13485 and/or GMP).
• Experience with ISO13485:2016 is advantageous.
• Strong working knowledge of cGMP and QMS frameworks, with proven experience in audits, document control, and change management.

Specific SHE Requirements:

• Pre-employment, routine, and exit medicals are compulsory due to the nature of the business.
• Mandatory attendance at SHE-related training.
• Adherence to SHE instructions and site rules.
• Ability and willingness to work with hazardous and biologically active chemicals, with the required PPE and medical examinations (per OSH Act).

Core Competencies:

• Strong leadership with the ability to influence, mentor, and build quality-driven teams.
• Excellent interpersonal skills with the ability to manage relationships across all levels of the business.
• Analytical mindset with strong problem-solving skills and attention to detail.
• Ability to manage projects and work independently with minimal supervision.
• Effective communicator, able to encourage teams to adopt process-oriented thinking.
• Strong technical writing skills and confident presentation abilities.
• High levels of personal leadership, initiative, and self-motivation.