Quality Specialist - Pharma MNC/ North #HZO

Duration: 6 months

Salary: $4500 - 8000 (Depending on experience)

Working Hours: 5 days office hours

Job Scope:

. Support the site projects on Qualification/ Validation

Assessment and Approval of Documents

. 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.

Job Requirements:

• Min. Degree in any relevant science field preferably in pharmaceutical or life sciences
• Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
• Min. 2-3 years relevant experience in pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation.
• 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.

For interested applicants, please send your updated resume to: [Confidential Information]

All candidates information will be treated with the strictest confidence

Melissa Zhang Zhiqi (Mezzo)

R2197564

Recruit Express Pte Ltd

99C4599