QA Specialist (Pharma) - 6months / NORTH #HHL

QA Specialist (Pharma) - 6 months / NORTH #HHL

Singapore | Posted: Nov 15, 2024

Contract Duration: 6 months
Working Hours: Monday to Friday, office hour
Location: Kranji
Start Date: ASAP

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, please submit your resume to alexgoh@recruitexpress.com.sg or telegram @alexgohhl.

Contact: Alex Goh Hock Leong

(CEI.No: R1763413 | Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)