Search Results: 8 vacancies
...have experience in Quality Assurance within a medical device company or pharmaceutical field.
Experience with regulatory affairs and CAPA an advantage.
Knowledge of Regulatory Requirements (MDD/MDR or FDA) an advantage
Key Competencies
Must have a flexible...
...regulatory and industry standards.
Perform routine entries in the local calibration maintenance software.
Participate in deviations CAPA s and change control s related to the maintenance of instruments in alignment with team priorities.
Provide support to maintain a...
...requirements for example CSV and SDLC.
Support the review & approval of key quality deliverables including SDLC Change control Deviations CAPAs. Etc.
Attend periodic review meetings cutover migration hyper care support any enhancements planning design and/or implementation...
...issues.
Contribute to the development and maintenance of the company's QMS, including the Corrective and Preventive Actions process (CAPA).
Assist in implementing plant-wide quality system improvements.
Maintain the internal audit schedule, conduct internal Quality...
...assessments and changes, ensuring appropriate actions are implemented timely.
Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
Provide QA oversight to GMP readiness,...
...Preventative actions are put in place to prevent recurrence. Support lead investigators and coordinate performance review of events trending for CAPA’s and NM’s.
· Review processes, facilities, procedures, and management of change documents to assure conformance to recognised EHS...
...involves supporting the operational activities including:
Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations.
Responsible for supporting execution of an effective Quality system and...
...actively to address compliance issues and achieve project milestones
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Lead and participate in investigation...