- Assume primary responsibility to support Quality Assurance management activities across assigned APAC markets. This to ensure products produced, imported and distributed by the affiliates are in compliance with quality and regulatory requirements (i.e. ASEAN GMP Guidelines, WHO GMP & GDP Guidelines, PIC/S GMP & GDP Guidelines, ISO 13485 & ISO 22716 standards) and to drive continuous improvement and support to affiliates in these areas.
- Quality Management
- Promote Quality and Technical management System principles in product life cycle
- Support and participate in regional audit plans to organize quality audits in affiliate contract manufacturer plants at pre-determined intervals.
- Review and finalize quality agreements within company and its Partners, and with affiliates (including contract manufacturers).
- Institute and review periodic (eg monthly or quarterly) quality/technical performance reports sent by contract manufacturers and re-packagers and follow up on potential sensitive items
- Quality Assurance Function
- Provide support to affiliates on quality matters relating to implementing company's quality requirements and to ensure regulatory compliance
- Specifically approve products validation protocols, review batch records, stability data/ reports, product specifications and any changes that could impact regulatory submissions. These are pertinent to existing products and new product introductions
- New product introduction and changes to existing presentations will require full review to consistently ensure safe, reliable and regulatory compliance
- Put process in place to provide quality technical inputs into supply chain management in relevant areas, namely, product sourcing, pack review, technical terms of supply, transportation contracts, audits of contractors and suppliers, product information sales pack
- Provide approval control for any repackaging activity
- Quality Processes
- Organize, record maintenance through key quality activities managed with a system of QMS, SOPs and Guidelines
- Manage change control
- In view of multiple company acquired products, help maintain a central product monograph system to manage, control, record changes and improve technical details of products.
- Compliance and Control
- Ensures processes and products comply with required standards including PIC/s, local cGMP regulations, international pharmacopoeias, registered product specifications, company standards, etc.
- Exercise ultimate Quality resolution on batches of incoming materials and of finish products
- Quality risk assessment
- Technical projects management
- Deviation, Change control, OOS decisions, technically related complaint resolutions
- University degree in Pharmacy / Science I Biological science / Bio technology or related field.
- 3 or more years managing multi-country or in-country quality management function in a pharmaceutical company with in-depth knowledge in pharmaceutics and formulations, process validation of multi dosage forms and product classes including injectables, OSD, OLD, topical, medical devices, IVDs, supplements & therapeutic cosmetics.
- Experience in all aspects of QC/QA work including understanding of chemistry and microbiology laboratories, implementation of specifications and product standards, quality assurance in manufacturing environment, working with suppliers to meet quality standards.
- Understand pharmaceutical productions processes, process validation, statistical process control, etc.
- Familiar with Quality performance measurement systems.
- Familiar with regulatory requirements in the Asia Pacific region.
Please contact Ewen Poh at +65 6950 0365 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1550486
Only successful candidates will be notified.