Senior Quality Assurance Executive

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 90,000 - 150,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd seeks a Lead QA Specialist to certify finished product batches and oversee all manufacturing stages for batch compliance with national requirements and GMP. The role supports annual quality reviews, incidents investigations, and cross-functional CAPA development.

Responsibilities include managing audits, risk management integration, change controls, and KPI tracking for product release. Strong English communication and proficiency in MS Office are essential.

Qualifications

• Bachelor-level degree in Pharmacy and relevant scientific fields is required.
• Experience in QA programs in pharmaceutical manufacturing is required.
• Familiarity with ISO, PIC/S and cGMP regulations is essential.

Responsibilities

• Certify product releases and ensure batch compliance with MA and GMP.
• Review BMR/CoA/Analytical Reports and support system releases.
• Lead quality improvement actions and CAPA programs with cross-functional teams.

Skills

Interpersonal skills

Communication skills

Attention to detail

Planning

Organizing

Critical thinking

Decision making

MS Office

Education

Degree in Pharmacy

Degree in Chemistry/Microbiology/Science/Engineering

Tools

Microsoft Office

Job description

Appointed as authorized person (AP) to certify product release and ensuring that each batch has been manufactured and checked in compliance with national requirements, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP) upon completion of AP qualification. The AP who performs certification of the finished product batch will assume full responsibility for all stages of manufacture of the batch or this responsibility may be shared with other AP who have provided confirmation for specified steps in the manufacture and control of a batch.

Product Approval and Release: ensure well planned and timely execution on BMR/CoA/Analytical Report review, approval and system releases.

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 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 support in implementation of Risk Management with integration of risk-based approach into all quality systems.

To support in Change Control implementation, impact assessment and change action verification, ensuring strategic alignment, minimize operational risk and continuous regulatory compliance.

Metrics Management End to End: track and monitor KPIs such as product release which is directly attributed by Plant Quality.

To continuously raise regulatory compliance by creating awareness of requirements and guidelines.

To coordinate and verify reprocessing and re-inspection activities with sampling inspection.

To maintain and establish the In-House Specification for commercial products.

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.

To report upwards for any anomaly conditions / deviation / non-conformances in timely manner.

Perform other duties as assigned based on business needs.

Degree in Pharmacy with minimum four years (Lead QA Specialist), three years (Senior QA Pharmacist), two years (QA Pharmacist) working experience; Degree in Chemistry, Microbiology, Science or Engineering, with minimum four years (Lead QA Specialist), three years (Senior QA Executive/ QA Executive I), and two years (QA Executive II) working experience in the quality assurance, quality control or related functions in a manufacturing operation.

Fresh graduate from Degree in Pharmacy (Provisionally Registered Pharmacist) or fresh graduate from Degree in Chemistry, Microbiology, Science or Engineering (QA Executive II).

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.

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.

What can I earn as a Quality Assurance Executive