Job Opportunity:
Quality Assurance Specialist
We are seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality management and be able to ensure ongoing compliance with relevant standards and regulations.
The key responsibilities of this role include:
* Validation Management: Design, execute, and report on PV/Process Performance Qualifications, validation studies for equipment, systems, and processes.
* Technical Interpretation: Provide technical interpretation and guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and dehydrogenation.
* Documentation: Maintain validation documentation throughout the validation lifecycle.
* Regulatory Compliance: Ensure validation studies are managed in conjunction with relevant standards and legal requirements (Health & Safety, cGMP, construction, environmental, etc.).
* Collaboration: Participate in external regulatory inspections and support Site Change Control process.
Requirements:
* Degree and Experience: Degree in Science (Chemistry, Micro., or Pharmacy preferred) or Engineering (Chemical/Mech/Elec), 3-5 years' experience working in a healthcare manufacturing environment – ideally within the pharmaceutical sector.
* Skills and Knowledge: Capable of troubleshooting validation issues associated with projects, process development, etc.; competent technical knowledge of pharmaceutical plants; previous validation/product development experience is highly advantageous.
* Industry Expertise: Familiarity with GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO guidelines.
* Quality Management: Strong understanding of quality management systems and relevant regulations.
Preferred Skills:
* Software Proficiency: Ability to use MS Project and SPC packages.
* Quality Management Systems: Good knowledge of quality management systems.
* KPIs: Understanding of KPIs for the site.