QA Validation Specialist
- Bachelor of Science or Engineering degree preferred
- Minimum of 3 years' experience in the pharmaceutical industry, preferably specializing in facilities and equipment validation, cleaning validation or equipment engineering.
- Well-developed technical writing and oral communication skills
- Demonstrated ability to manage multiple projects and tasks concurrently and effectively
- Good understanding of validation principles as applied to processes, equipment, cleaning and/or facilities
- Understanding of formulation, manufacturing principles and manufacturing and packaging equipment
- Good overall knowledge of pharmaceutical business operations within scope of job
- Strong knowledge of cGMPs and QMS pertaining to validation
- Demonstrated risk-based decision making skills
- Demonstrated proficiency in computer systems.
- Confident presentation/communication skills – willing to make decisions with support
- Superb ability to use collaborative skills to develop rapport with internal stakeholders
- Demonstrated ability to prioritize work and adapt to change
- Ability to work independently to meet demanding objectives and tight deadlines.
- Knowledge of Solid Dose, Liquids/Topicals product processes is an asset
- Good understanding of engineering principles and IQ, OQ, PQ documentation is an asset
This is a 12-month contract
- Review and approve Installation Qualification (IQ) and Operational Qualification (OQ) documents relating to concurrent validation activities for product manufacturing and packaging
- Prepare or review final validation summary reports for Facility or Equipment Systems
- Perform data review activities to support the validation team (Process, Facility, Cleaning validation)
- Compile and assess data, conduct statistical analysis for the risk assessment and validation summary reports, ensuring conclusions are based on validated parameters
- Perform critical parameter checks for products by verifying production batch records against PQ studies to ensure compliance
- Evaluate all proposed changes for potential impact on the validation of product, processes, cleaning methods, or facilities. A higher emphasis will be placed on process activities (manufacturing/packaging).
As required, develop validation studies to support the changes.
- Conduct and document validation reviews for manufacturing and packaging processes, equipment validation, equipment cleaning processes, and facilities systems. Make recommendations and ensure completion of actions.
- Create and maintain validation templates, SOPs, Master Forms and other essential tools
- Support process hold time data for bulk products as well as develop equipment cleaning parameters (e.g. dirty hold times, campaign parameters, etc.)
- Create Validation Master Plans and Validation Plans for Manufacturing and Packaging processes
- Ensure project & documentation compliance with external regulatory (HPFBI, FDA) and QMS requirements
- Promote clear communication with Production staff, QA, QC, Engineering and Site Management
- Provide guidance to Engineering, Technical and Production partners on validation decisions
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]
You may apply for this position online by selecting the Apply now button.
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