Quality Assurance Executive

Position: Quality Assurance Executive/Pharmacist

Workbase: Cheng, Melaka

Job Outline:

Responsible to support in conducting investigation on Customer Complaint, product recall, out of trend and out of specification. To support in executing and implementing Annual Product Quality Review, Validation Master Plan, Good Distribution / Warehouse practice, risk management, post market surveillance, management review, electronic Quality System E-tools, stability study management, change control implementation verification, product release and quality improvement programs. Also perform all duties related to auditing and documentation of compliance related items against current regulatory, GMP and ISO standards.

Duties and Responsibilities:

• To support in preparation of the annual product quality review and implement on-going verification of product performance, ensure annual product quality review is carried out with trending analysis and conclude with sound recommendation on improvement plans. Ensure on time implementation of agreed actions.
• To support in complaints and product recall investigations, establish oversight and governance process upon complaint receipt and trigger of the product recall throughout till closure of the complaint and recall.
• To perform failure investigation (Deviation) and propose quality CAPA, establish system with well-defined roles and responsibility of cross functional team, process if investigation inclusive timeline, quality of root cause analysis, quality of proposed CAPA, effectiveness check upon closure etc, to avoid recurrence of similar root cause.
• To investigate the potential root causes on out of trend and out of specification issue in product stability studies program and finished product analysis, where priority on patient safety would be addressed and appropriate preventive actions are implemented with closely monitoring and documented.
• To support on deployment and implementation of Good Distribution/Good Warehouse Practice. To perform temperature mapping activities for warehouse and manufacturing plant as well as transportation in compliance to Good Distribution Practice. To document the result of temperature mapping timely and accurately.
• To assist in preparation of annual Validation Master Plan and organize periodic progression reviews where issues are attended to and required resources are channeled accordingly. To perform site verification on qualification and validation.
• To support in overall Audit Management (mainly internal audit, regulatory, customer, certification body and health authority audit).
• Electronic Quality System E-tools custodian, to design, validate and implement with supports from IT function.
• To implement Risk Management.
• To support in Post Market Surveillance activities.
• To support in execution of management review; prepare presentation slides, coordination of the meeting and writing of meeting minutes.
• To support in Site Master Plan, Quality policy, CP and SOP deployment, to establish, maintain and control.
• To support in implementing the Stability Study Management Program according to standard operating procedure, ensure accuracy and maintenance of stability study program documents and prepare stability study reports.
• To propose and execute quality improvement program with robustness quality evidence been demonstrated and maintained. It shall be validated and documented for effectiveness of intended outcomes.
• Product Approval and Release: ensure well planned and timely execution on BMR/CoA/Analytical Report review, approval and system releases upon successful qualification.
• Change Control Implementation and closure verification.
• To report upwards for any anomaly conditions / deviation / non-conformances in timely manner.
• Perform other duties as assigned based on business needs.

Minimum Requirements:

• Degree in Pharmacy with minimum two years working experience, degree in Chemistry, Microbiology, Science or Engineering, with minimum two years (QA Executive II) and three years (QA Executive I) in the quality assurance, quality control or related functions in a manufacturing operation.
• Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.
• Good knowledge of ISO and PIC/S regulations and cGMP is required.
• Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.
• Attention to detail, possess planning and organizing skills, critical thinking skills, judgment skills and decision-making skills.
• Proficient in Microsoft office applications.