Head Quality Assurance - OSD Facility

Responsibilities

• To ensure that quality systems are developed, implemented and maintained.
• To ensure that the raw material suppliers are qualified as per the applicable procedures.
• Oversee investigations of all non-conformances (Incidents, deviations, OOS, market complaints, errors, etc.).
• Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company.
• To ensure qualification and validation are performed as per SOP and regulatory requirements for Process, cleaning, systems, equipment, and computerized system.
• 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 program in place that is communicated to Operations to meet the requirements of USFDA / WHO-GMP /EU GMP/PICS/TGA/ ANVISA / MHRA etc.
• Management of the clients and act as a CMO adequately and in a timely manner.
• To ensure participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvement.
• Responsible for the management of approval and release of the batch.
• Coordinate during technology transfer of products to the site.
• Responsible for review, approval, implementation, and verification of Corrective Action and Preventive Action.
• To ensure compliance with audit observations for external audits/self-inspections.
• Responsible for management of quality agreement and its compliance and review and approval for Artwork and Risk Assessments.
• Coordinate with the Finished Goods dispatch team, prioritize the analysis as per dispatch exigencies, and release the batches within the stipulated time frame as per the dispatch plan.
• Strategic planning and execution of Quality Management System, organizing QMS review meetings and acting as management representative during Quality Review Meetings.
• To provide Quality guidance to product development projects, Tech Transfer of products & Programs.
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company SOP and external and internal customers, with respect to quality, service, lead time, and cost.
• Procedures (GTP) and etc. of the Quality Control Department 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.
• To conduct interviews and recruitment of Quality Assurance personnel.
• 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.