General
- Manage and maintain quality documents/ procedures/ records in compliance with regulations and SOPs.
- Complete training on time and before carrying out the assigned tasks.
- Actioning assigned change controls, change actions, deviations, NCRs and CAPAs.
- Carry out the assigned tasks in compliance to GMP and SOPs and in alignment with defined timeframes and business needs.
- Notify and escalate issues related to tasks to reporting manager for potential issues which may risk the business activities.
- Quality oversight of contract manufacturers including: DOS/NCR/Deviation and CAPA, Change Control and routine stability testing monitoring. On time and in compliance to GMP and applicable standards
- No recalls or Critical product quality issue on product in the market due to batch release oversight.
- Release timeframe within target timeframe
- Oversight and management of change control process.
- Change Controls and tasks to be actioned within the defined target dates and in compliance to GMP and SOPs.
- Artwork review according to requirement
- Oversight and management of process.
- Deviations to be completed in compliance with GMP SOPs and SOPs with timeframes of business needs
- No recalls or Critical product quality issue on products in the market due to due diligence oversight.
- Work with internal departments and 3rd party suppliers to maintain oversight of the complaints process to ensure complaints are managed according to compliance requirements.
- Complaints resolved within required timeframes as defined in SOPs and according to the compliance requirements of regulations and SOPS.
- Timely reporting of complaints.
- Maintain and implement the quality risk management process
- Support in annual management review
- Participate in due diligence checks for new suppliers/ products and support in supplier audit management.
- Other projects of duties as per assignment
Requirement
- Min. Degree / Diploma in Chemistry / Pharmacy or other engineering
- Min. 1 year of experience in Pharmaceutical / medical device industry with at least 1 year of QA or GMP environment
- Experience in Supply chain quality , manufacturing quality or quality organisation in commercial needs
- Good knowledge of deviation management , CAPA ,change control and document management in pharma / medical device industry
If interested, please email your resume to [email protected]
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
