QA Validation Specialist (GMP/ CAPA/ Pharma) - #1090977

Senior QA Validation Specialist (GMP/ CAPA/ Pharma)

15 Months Contract 

Location: Tuas 

Up to $5,000 depending on experience 

Industry: Pharmaceutical 

Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.

Job Summary:

• Responsible by leading and/or executing validation activities including equipment, process, test method and software validation by ensuring that products are manufactured consistently and reliably as according to good manufacturing practices (GMP). 
• Ensure smooth execution and quality oversight of qualification and validation activities. 

Responsibilities: 

• Provide validation expertise during the development and implementation of new process, equipment and technologies.
• Ensure that equipment, facilities and system are qualified and validated by reviewing and approving the qualification and validation documentation which include test scripts, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, deviations, reports, risk assessments and traceability matrices according to pre-defined timelines.
• Investigate and resolve validation-related issues, deviations and non-conformities to recommend corrective and preventive actions. Ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards.
• Identify opportunities for improving qualification and validation processes and contribute to continuous improvement initiatives. Support improvement projects by ensuring the validation/qualification are executed with conformance to GMP e.g., review of validation/qualification protocols and reports.
• Be the quality qualification and validation representative for quality (Q)& validation (V) projects for new and existing equipment and facilities within the defined scope. Writes/reviews protocols and reports related to equipment /analytical validation and qualification activities. 
• Supports in regulatory inspections and audits (if any), provides quality validation support, and support site experts (i.e. users, Process & Technology, production, or Engineering.)
• Collaborate with cross-functional teams i.e., process & technology, manufacturing operations, engineering, supply chain and quality control to ensure seamless integration of validated system and process. 
• Training: To complete all GMP mandatory and related trainings
• Facilitate daily level 2 quality meeting. Backup as QA Executive for QA team. Support monthly joint GEMBA- backup as QA Executive for QA team.
• Play a pro-active role by complying and adhering to HSE guidelines. Embrace always Zero Incident Mindset and adopt the responsibility of HSE protection policies and Life Saving Rules (LSR).
• Other responsibilities that are not included in the above but are related to quality assurance and in accordance with internal guidelines/SOP as and when assigned by supervisor/manager.

Requirements:

• Hold a bachelor Degree or equivalent from recognised institution with minimum 3 years of experience in Quality Validation in the pharmaceutical/biotech industry or equivalent holders with a combination of education and relevant work experience. 
• Experience in QC with laboratory expertise background 
• Meaningful work experience in validation/quality unit in pharmaceutical/biotech industry. 
• Familiarity with regulatory requirements and local codes & standard e.g., FDA, EMEA and ICHQ7. 
• Fair knowledge of validation lifecycle approach (URS, FAT/SAT, commissioning, I/O/OQ/PQ protocols etc) and regulatory guidelines in a GMP facility. Familiarity with industry best practices for qualification of SAP system. 
• Experience with investigations into manufacturing, laboratory deviations and product impact on potential root cause and corrective/preventive actions. 
• Able to work independently and write/review quality validation reports which include equipment /analytical validation and qualification activities. 

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423