Responsibilities

• Support the site projects on Qualification/ Validation
• Responsible to review and approve the Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.
•   Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.
• Provide validation expertise, oversight and support for the development (or modification phases) of Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification.
• Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.
• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.
• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.
• Build strong partnership with all other departments to ensure open communications and acceptance
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
• Any other duties as assigned by Manager/ Supervisor.

Education and Experience Requirements

• The candidate should have at least have a degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline. Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• A minimum experience of 2-3 years in the pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation, ideally in a multinational company. Hands-on experience with hands-on experience in performing equipment, process, cleaning, computer systems & shipping validation will be advantages.
• FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc.
• Able to logically solve problems in order to find timely solutions.
• An ability to interact and communicate with all types of personalities in an effective and diplomatic manner. 

Apply now by sending your resume to: ashley.loo@recruitexpress.com.sg

We regret to inform that only shortlisted candidates will be notified.

Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599

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