Contract Quality System/ Assurance Specialist - PHARMA, EAST
Recruit Express Pte Ltd| Date Posted: 18-Jan-2021
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Diploma, Bachelor's / Honours
- Work on compliance activities associated such as fulfilling FDA QSR/part 11 data integrity, ISO13485, cGMP, etc.
- Evaluate procedural compliance such as review and develop procedures and determine appropriate escalation process as required and take necessary action (s), ensure training records are filed before release.
- Conduct investigation and analysis of customer complaints; highlight the trends to manufacturing for improvements.
- Coordinate Change Management includes chair change meeting, update change masterlog and follow up with the change owner for closure, ensure the changes are captured and documented and risks are evaluated, this is not limited to internal changes, also includes the changes initiated from suppliers or triggered by customers, Maintain change record filing.
- Drive CAPA meeting, work with cross-functional team for solution implementation and effectiveness of the solution, maintain proper records of CAPA and conduct monthly data trend.
- Performance Internal Audit to identify gaps in compliance or nonconformance for the site, ensure audit reports are approved and filed timely, ensure audit findings are closely monitored and closed with objective evidence.
- Work closely with cross-functional team to ensure that QMS processes remain relevant and compliant to applicable internal and external requirements, and provide guidance to the key stakeholders on overall QMS regulations, includes the support of new production transfer and validation activities.
- Other duties may be assigned.
- Bachelor’s degree or equivalent in a related life science/technical discipline or equivalent preferred.
- Understanding of GMP and quality system standards
- Working knowledge of device/drug/biotech manufacturing processes.
- Detail-oriented and ability to multitask.
- Problem solving, decision making, time management, organization, communication, and computer skills.
- 5+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
- Familiar with Quality Systems, including but not limited to investigations, qualifications, validations, CAPA, and NC is also required.
- Excellent communication skills.
- Demonstrated proficiency in use of engineering tools - FMEA, SPC or equivalent statistical tools, etc.
- Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
- Knowledge of ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device Directives.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd