QA Validation Expert (Pharmaceutical/Commissioning/ Quality)

QA Validation Expert (Pharmaceutical/Commissioning/ Quality)

Location: Gul Circle

Up to $8,500 depending on experience

12 Months Contract

Industry: Pharmaceutical

Job Purpose

• Responsible to partner with cross-functional teams to provide quality oversight to commissioning, qualification, and validation (CQV) lifecycle activities ensuring compliance with company’s quality requirements and the applicable regulatory expectations.
• Oversee the validation of Facilities, utilities, equipment (FUE), decontamination and manufacturing processes.
• Responsible for ensuring that effective process control measures to assure quality of the product(s) have been identified and implemented.

Responsibilities:

• Provide quality oversight to validation/qualification and continued verification of (but not limited to) the following:

1. Facilities, utilities, equipment
2. Computerized systems
3. Decontamination (including cleaning and disinfection)
4. Manufacturing (including buffer and media preparation) processes
5. Shipping/transportation

• Support, through risk facilitation and/or participation, or as an SME, quality risk management activities including, but not limited to the following: manufacturing process risk assessments, shipping risk assessments, hold time studies, assessment of Extractables and Leachables.
• Work in close collaboration with stakeholders in establishing holistic control strategy to ensure appropriate process controls to eliminate and/or reduce any identified quality risks have been identified and implemented.
• Function as a key quality reviewer and approver of CQV lifecycle documents, including user requirements specifications, validation plans, risk assessments, engineering drawings, protocols, and reports.
• Review, evaluate, and approve CQV related non-conformities and changes, and support investigations and corrective actions.
• Liaise with CQV project team to ensure all deliverables are met on time.
• Ensure all qualification/validation are successfully concluded, all documentation completed, and all non-conformities are addressed, before the systems are released for GMP use.
• Responsible for ensuring all CQV activities meet Sanofi’s quality requirements and fulfil regulatory expectations.
• Partner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives.

Requirements:

• Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
• A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
• Sound knowledge and understanding of regulatory requirements and industry best practices (e.g., ISO, ASTM, ISPE, PDA) pertaining to management of validation lifecycle.
• Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and their application to validation of systems
• Solid technical knowledge in the use and application of risk- and science-based approaches to validation.
• Experience in greenfield/brownfield facility start-ups
• Familiar with Digital 4.0 concepts and potential applications in Quality.

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423