What are the responsibilities and job description for the GMP Validation Expert position at Apex Systems?
We are looking for an experienced Pharmaceutical Equipment Specialist to join our team at Apex Systems. The ideal candidate will come from a Quality Engineering background and/or possess a chemical engineering degree.
The successful candidate will be responsible for managing all technical aspects of assigned products and/or new processes in manufacturing. This includes writing and validating IQOQs, preparing batch log records and cleaning log records, supporting production, conducting investigations, implementing corrective actions, and improving yields and cycle times.
- Closely collaborate with the Engineering and Chemical Development departments for equipment validation.
- Validate new equipment according to approved testing plans and report results accordingly.
- Develop and write GMO qualifications for new pharmaceutical equipment using templates.
- Adhere to personal moral, ethical, legal, and behavioral conduct in compliance with the Code of Conduct.
- Implement and adhere to all applicable SHE, DEA, and cGMP regulations.
Key qualifications and responsibilities include:
- A 4-year degree in Chemical Engineering is desired, along with 1-5 years of hands-on experience in a pharmaceutical or fine chemical batch plant.
- Experience with Drug Substance/API Pharma processing equipment.
- Ability to review and summarize data from equipment validation studies and write summary reports for Quality approval.
Requirements also include excellent verbal and written communication skills, being highly conscientious and detail-oriented, and ability to work efficiently with people of all levels and cultures.
