Contract Duration: 6 months
Working Hours: Monday to Friday, office hour
Location: Kranji
Start Date: ASAP
Salary: 6000-8000
Responsibilities :
- Support site projects on Qualification/Validation.
- Review and approve Quality Control related protocols, reports, procedures, and other documents.
- Evaluate and approve discrepancies related to qualification/validation protocols.
- Collaborate and participate in projects as a Quality Representative for Quality Systems and Validation.
- Provide validation expertise and support for Analytical Instrument Qualification, Analytical and Microbiology Method Validation, and Critical Reagent Qualification.
- Ensure information in approved qualification/validation documents is understandable and defendable during inspections.
- Provide quality oversight on Quality Control validation maintenance activities and the Master Validation Plan.
- Support multisite initiatives to harmonize Quality Systems and qualification/validation activities between plants.
- Build strong partnerships with other departments to ensure open communication and acceptance.
- Adhere to applicable EHS requirements.
- Commit to fair and respectful relationships and behavior in accordance with the company's Code of Conduct.
- Perform other duties as assigned by the Manager/Supervisor.
Education and Experience Requirements:
- Min. Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, engineering, or a related discipline.
- Additional certifications and training such as Certified Quality Engineer or specific Validation topics are advantageous.
- Minimum of 2-3 years of experience in the pharmaceutical or biotechnology industry in quality assurance, manufacturing operations, or validation, ideally in a multinational company.
- Hands-on experience in performing equipment, process, cleaning, computer systems, and shipping validation is advantageous.
- Knowledge of FDA/EU cGMP validation requirements/expectations (e.g., CFR 21 part 11, PAT) and ICH guidelines.
Interested candidates, do submit your resume to [email protected] or telegram @alexgohhl
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Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
