Quality Assurance & Control (Manufacturing, Transport & Logistics)
Full time
Minimum education: Registered Pharmacist
Have job experience in Pharmaceutical industry as Quality Control Manager at least 5 years
Practical experience of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and its application
Practical experience of Health & Safety in laboratory
Extensive experience with laboratory out of specification (OOE) investigations.
Demonstrable leadership, communication skills and managing team
Excellent planning, organizational and prioritization skills.
Ability to identify skill gaps within team and formulate a training and development plan
Application and knowledge of risk management strategies.
Ability to develop and maintain effective working relationships with colleagues and other company personnel across a diverse workforce.
Ability to work in a team which has both internal and external business reporting relationships
Responsibilities:
Review and authorization of finished product, raw material and packing material specifications.
Ensure compliance with GMP or alternative local regulations in relevance with the quality of finish products.
To regulate and ensure the testing of all samples is conducted in accordance with the procedures or methods that have been validated and approved properly.
Ensuring the QC laboratory is fully stocked and equipped to perform the necessary activities.
Maintain and monitor project progress related to QC, including managing project budget, resources, risk and issues.
Lead Out of Specification (OOS) and Out of Expectation (OOE) investigations by applying initiative and problem-solving skills.
Forecasts, prepares and monitors the operating, personnel and capital expenses budgets in Quality Control area.
Review, manage and optimize the performance of staff and resources.
Tracking of agreed KPI’s, preparation of reports on agreed performance criteria for the QC department, along with the preparation of reports as required to senior management and across site.
Adherence of testing schedules as planned in order to meet demand.
Ensure maximum co-operation and communication between Quality Control and other departments, to ensure optimum performance levels consistent with the achievement of business plans.