Head of Quality Control
4 weeks ago
Msc-Analytical chemistry. - Must
Key Competencies : Passion for Excellence
- Leadership & Team Management
- Result Orientation & Multi Tasking
- Good Communication Skills
- Head Quality is accountable for ensuring the all-time readiness of plant for various GMP compliance audits, being the single point contact on all Quality matters.
Quality Assurance :
- Develop, implement, manage, audit and maintain GMP quality systems.
- Coordinate and perform all vendor qualification and compliance audits.
- Develop, manage and maintain a GMP compliant document control system.
- Oversee investigations of all non-conformances (deviations, errors etc.).
- Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
- Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
- Provide quality guidance to product development projects and programs.
- Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
- Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being - fit for purpose- operationally and commercially.
- Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
- Ensuring that there is a self inspection programme in place which is communicated to Operations to meet the requirements of EU GMP/PICS/TG/MHRA etc
Quality Control :
- Managing all validation activities, including validation strategy and approval of protocols and reports.
- Develop, communicate & adhere to best Testing practices to ensure that no non-conforming batch leaves Company premise
- Ensure qualification & maintenance of equipment's, department & premises.
- Ensure optimum utilization of the resources available so as to comply with the agreed timelines with customers, internal & external.
- Ensure - ZERO- down-time for want of maintenance of machines, manpower & material
- Observing and complying with GLP.
Management :
- High level resource planning.
- Represent QA at senior management, project, Board, and review meetings.
- Providing direction and guidance to the Quality team.
- Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.
- Identifying and developing the Quality team structure.
- Preparing and justifying the Quality department's budget.
- Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
- Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.
- Budgetary and managerial responsibility for Quality Assurance and Quality Control.
Person Profile :
- Msc-Analytical chemistry.
- Quality professional with 18+ years of hands on experience with increasing responsibility in a QA function.
- Prior responsibility for Quality Control.
- Hands on experience implementing quality systems in a GMP environment, and direct experience with FDA and other health authority inspections.
- Extensive knowledge of various GMP compliances regulations and industry practices.
- Ability to critically evaluate and troubleshoot complex problems is essential.
- Strong hands on leadership and management skills with a - can do- attitude.
- Ability to effectively participate on multi-disciplinary teams.
- Ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
- Good understanding of the pharmaceutical market, including the unlicensed medicines sector.
- Wide knowledge of products and processes used in the manufacture of unlicensed medicines.
- Strategic thinker with the ability to influence at a senior level.
- Highly customer focused.
- Commercially astute.
- Strong analytical and problem solving ability.
- Excellent project management skills.
- Adept at Conflict Management & resolution
Additional Information
All your information will be kept confidential according to EEO guidelines.
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