Senior Executive, Quality Assurance (Pharmaceutical)

Senior Executive, Quality Assurance (Pharmaceutical)

Ensure all quality-related matters and overall GMP practices comply with PIC / S requirements, other applicable standards, and the company’s quality requirements to consistently deliver high-quality products for Duopharma HAPI Sdn. Bhd.

Monitor, check, evaluate, and assess all activities and documentation in line with the Quality Management System (QMS) , incorporating Good Manufacturing Practice and relevant regulatory standards.

KEY ACCOUNTABILITIES

Conduct GMP training sessions, including participant assessments and evaluations, and assist in organizing and delivering QA-planned GMP training for all departments to support continuous understanding, application, and compliance with GMP.

Review validation documents for accuracy and GMP compliance, ensuring adherence to standard formats, timely reviews, and proper distribution.

Review batch records, finished product testing reports, and all related quality records before making batch disposition decisions.

Prepare Product Quality Review (PQR) reports according to planned schedules and assess data trends.

Manage change control projects, coordinating with initiators to resolve issues and ensure timely completion.

Oversee the workflow, coordination, and implementation of the Novatek Incident & CAPA module.

Escalate major non-conformances and product quality issues to the QA Head of Department (HOD) and Operations Manager for immediate action.

Provide advice and assistance on practical operational changes and quality system improvements, recommending and implementing process, procedural, and system enhancements, and resolving quality problems from both internal and supplier sources.

Serve as GMP lead auditor or auditor for internal and vendor audits; participate in external audits and assist in vendor audit logistics and coordination.

Act as Audit Coordinator for internal, vendor, and regulatory audits to ensure GMP and regulatory compliance.

Evaluate, manage, and ensure regulatory compliance concerning nitrosamine impurities (including NDMA and NDSRIs) in pharmaceutical products.

Lead the development, review, implementation, and monitoring of Quality Technical Agreements (QTAs) with third-party manufacturers, service providers, and partners.

Serve as Training Coordinator, responsible for planning, organizing, and maintaining the site’s training program to ensure employee competency and regulatory / GMP compliance.

Review documentation and manage disposition of traded cold chain products in compliance with standards, ensuring timely closure of any related incidents.

Lead regulatory correspondence related to filings, providing complete and timely responses to ensure quality-related communications are appropriately managed.

PERSON SPECIFICATIONS

Qualifications

Bachelor’s Degree in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry & Technology, Biology, or other related science / technology fields.

Experience

Minimum of five (5) years’ experience in the pharmaceutical industry, preferably in Quality Assurance (QA), Quality Control (QC), or Validation.

Specialized Knowledge

In-depth knowledge of pharmaceutical GMP.

Familiarity with Pharmaceutical Quality Management Systems (QMS).

Knowledge of GMP and Quality Systems (preferred).

Familiarity with SAP (preferred).

Proficient in Microsoft Office (Word, Excel, PowerPoint).

Delivers all assigned tasks on time; demonstrates independence, organization, compliance adherence, and initiative in learning and task completion.

Works effectively in a team and treats others with respect.

Strong interpersonal skills to work across all organizational levels.

Duopharma Biotech Bhd is a dynamic and progressive pharmaceutical manufacturing company committed to serving the national healthcare and enhancing quality of life.

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