Senior QA Project Executive

Purpose

The (Senior) Quality Assurance Executive is reponsible for providing quality input and oversight on the following areas during the new product introduction to Singapore Tuas site.a. Product transfer of new productb. Design, construction, commissioning and qualification of facility, equipment, utilities, automation, digitalisation.c. Introduction and qualification of materiald. Introduction and qualification of quality control test method for materials and producte. Supplier and Service assessment of new materials, equipment or automation system supplier and services to GSKf. Implementation of Contamination control and cross contamination controlg. Implementation of operating and testing procedure and trainingh. Introduction of electronic batch record and quality control test recordHe/She is expected to partner with all project members to anticipate, prepare and meet project deliverables on all phases of the project.As a Quality Assurance executive, he/ she represents the project team and point of contact on project quality matters related to process equipment and material related activities. He/ she establishes effective working relationship with quality functions of supplier for facility, equipment, systems and material commissioning and qualification, global QA in GSK Vaccines and local site QA in Tuas.The QA executive ensures that all product transfer, commissioning, qualification as well as routine implementation activities under the project scope is designed in compliance with all applicable GSK Quality policies, regulatory requirement, and GMP practices/ procedures in place and in use within GSK Tuas.

Key Responsibilities

1. General Project Quality Management

• Ensure quality-by-design in all aspects and stages of the project is in alignment with the defined Project Quality System and Quality Plan
• Accountable for quality inputs and ensure compliance to regulatory requirement, quality management system (QMS) and local procedures throughout the project lifecycle with regards to qualification and validation
• Deploys the appropriate project documentation through the project lifecycle
• Develop and align strategy and deliverables with project stakeholders to meet project milestones for material , facility, equipment, utilities, automation, digitalisation, product transfer and QC method
• Identify and anticipate potential quality issue during the course of the project execution and avoid / minimise disruption to operations and compliance of GMPs.
• Execute quality compliance gap assessment exercises at appropriate stage of the project lifecycle
• Ensure proper ties-in strategies and solutions between new facility and existing GMP areas to avoid / minimise disruptions to routine GMP operations.
• Timely and compliant resolution of quality issues related to manufacturing and / or Quality Control functions to meet product timeline, GMP requirements and regulatory expectations.
• Project documentation records are compatible and easily accessible using site documentation system
• Key project risks and gaps are timely identified and mitigated.

2. Facility, Equipment, System Design,  Development and Qualification 

• Define commissioning and validation approach and ensure deliverables are met per commissioning and validation plan to achieve validation status of the facility, equipment, technology and system.
• As an oversight of the validation activities, ensure all commissioning and validation requirement are met.
• Ensure timely completion of validation activities as per project schedule.
• New Supplier and Service management of equipment and system supplier or service provider including supplier assessment.

3. New Material Introduction and Qualification

• Review and approve new material and service introduction forms
• Ensure new materials are introduced for material qualification, engineering runs and process validation timely as per schedule
• New Supplier and Service management including supplier quality agreement, technical terms of supply, supplier assessment
• Ensure viral, bioburden, extractable and leachable risk are mitigated at qualification stage.

4. Product transfer and method verification / validation

• Develop and align strategy and deliverables with project stakeholders to meet project milestones for product transfer and QC method and reagent qualification strategy and deliverables
• Support new product introduction, technological transfer, method transfer from other sites to ensure timely completion and compliance to relevant requirements

5. Review and approval of project related documentation as assigned, for example:

• LSOPs / Checklists / Joblists
• Master Data Change Requests
• Master Batch Records and checklists including executed records
• Analytical Protocols and Reports
• Compendial gap assessments
• Deviations / Events / Incidents
• CAPAs
• Change Controls
• Quality Tag Outs
• Trial Risk Assessment
• QC / Batch usage decisions such as sterile buffers and / or intermediates and movement of batches to restricted status as required.
• Any other project documents as required.

6.   EHS (Environment, Health and Safety)

• Comply with company requirements on EHS.

Skills, Knowledge & Experience

Professional

Qualification:

• At least University basic degree in Science or Engineering disciplines

Experience:

• At least 3 years experience in Pharmaceutical industry (For QA Executive)
• At least 5 years experience in Pharmaceutical industry (For Senior QA Executive)
   

Technical

• Understanding of cGMP and regulatory requirement within Pharmaceutical industry 
• Good knowledge of safety and environmental regulation
• Hands-on experience in Pharmaceutical manufacturing (Preferred)
• Developing Project management skills or had hands-on experience in Project management (Preferred)

Business

• Ability to apply optimal quality assurance standards to support project tem and facility the timely progress of the project milestones
• Ability to facilitiate project deliverables compatible to international regulatory environment
• Ability to communicate to and influence stakeholders effectively
• Ability to apply risk management skills adequately

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