Our Client is a US MNC and a pioneering leader in the Pharmaceutical industry. They are currently seeking experienced and motivated professionals to join their Quality Assurance Team.
QA Specialist (shift work)
Responsibilities;
- Product Annual Review: Initiates and facilitates Product Annual Review activities, Tracks recommendations and ensures action plan completion & Compiles reports for approval.
- Deviation/OOS/Customer Complaints: Participates in investigations, reviews and approves investigation reports, Tracks Corrective Actions/Preventive Actions, etc.
- Product Release: Performs batch disposition and updates in the system, Reviews and closes batch-sheet and related documentation, etc.
- Change Control: Reviews and approves change control request, qualification activities from quality perspective. Acts as Quality representative in change control meetings.
- Develop and oversee plans for capital projects or initiatives such as new product introduction.
- Maintains appropriate quality oversight of SOPs for manufacturing and operational activities.
- Approval of IQ, OQ, and PQ protocols for complex systems. Identifies validation issues and supports development of remedial actions.
Requirements;
- Graduate in Science/Life science, Pharmaceutical Science or Chemical Engineering
- Minimum 3 years of relevant experience in quality assurance in pharmaceutical / bio pharmaceutical manufacturing environment, supplying to highly regulated markets such as FDA and EMA.
- Comfortable working shift hours.
- Quality assurance/operations experience in a sterile manufacturing plant is strongly preferred.
- Proactively anticipating quality risk across various phases of product lifecycle to develop and integrate improved mitigation plan and techniques based upon product types and associated technologies.
- Demonstrate the ability to independently solve problems and make prompt decisions as guided by policies and procedures.
Other information;
Shift work; (3 shift; night shift is from 10pm - 6am)
Location: Tuas
12 months Contract Renewable basis
Interested applicants, please submit resume in MS word doc format to; yenleng.yap@manpower.com.sg (R1110894)
Yen Leng Yap EA License No. 02C3423 Personnel Registration No. R1110894
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