Job Title: Quality Assurance Specialist
We are seeking a skilled quality assurance specialist to support new product introductions, equipment qualification and the site requalification program.
Main Responsibilities:
* Designing, executing and reporting on PV/Process Performance Qualifications.
* Designing, executing and reporting on validation studies for equipment, systems and processes.
* Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
* Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and dehydrogenation.
* Ensuring that the validation status of equipment and systems are compliant with cGMP at all times.
* Maintaining validation documentation through the validation lifecycle.
* Participation in external regulatory inspections.
Qualifications & Experience:
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mech/Elec).
* 3-5 years experience working in a healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector.
* Capable of troubleshooting validation issues associated with projects, process development etc.
* Competent technical knowledge of pharmaceutical plants.
* Previous validation/product development experience would be highly advantageous for the role.
* Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
* Knowledge of requirements for GAMP, ISPE Baseline guides.
* Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
* Full understanding of relevant quality and compliance regulations.
* Able to execute projects to plan.
* Good knowledge of quality management systems.
* Ability to use MS Project and SPC packages an advantage.
* Understands KPIs for the site.
The ideal candidate will have excellent analytical and problem-solving skills, strong attention to detail and ability to work independently with minimal supervision. They will also possess excellent communication and interpersonal skills and be able to effectively collaborate with cross-functional teams.