
Change Control Specialist
6 days ago
We are currently recruiting for a Change Control Specialist role with an international organization based in Cork. This is an excellent opportunity to join a multinational company that excels in its industry.
Duties include providing technical support for vaccine drug substance and/or drug product processes to ensure compliance with European Pharmacopoeia (EP) standards, including person-in-plant support within the manufacturing facility.
The successful candidate will also be responsible for supporting Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ), as well as collaborating across multiple technical functions to ensure successful commercial manufacture.
An advanced degree in Engineering or Science is preferred, but not required. A Bachelor's degree is acceptable if accompanied by relevant experience in pharmaceutical manufacturing, engineering, and/or technical support.
- Key Responsibilities:
- Provide technical support for vaccine drug substance and/or drug product processes
- Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ)
- Collaborate across multiple technical functions to ensure successful commercial manufacture
- Author process change control documentation, technical communications, and process risk management documents
- Lead team for identification and assessment of partner risks and develop mitigation plans
- Investigate and coordinate issue resolution with other impacted sites
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