Description
Primary Tasks and Responsibilities- Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements
- Develop validation documentation as required
- Review and approve documents prepared by the validation team, other departments and contractor organisations
- Execute qualification protocols as required
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports
- Prepare reports of executed protocols for review by QA
- Initiate and implement change control activities in accordance with site procedures
- Track and resolve exceptions during qualification activities
- Prioritize qualification activities in line with the project schedule
- Co-ordinate qualification activities with engineering, construction and commissioning activities
- Co-ordinate qualification activities with contractors and vendors as required
- Co-ordinate qualification document review and approval
- Collate and organize qualification files for turnover to QADC
- Assist in the development of training material for qualification activities.
- Deputises for the QA Validation Manager when designated as appropriate.
- Domestic and international travel may be required.
- Participate in cross-functional teams as required.
- Attend identified training
DESIRABLE:
- The person will have a proven track record in the qualification of any of the following systems:
o Qualification of Cell Culture Technologies.
o Qualification of Purification - Chromatography and Ultrafiltration Technologies.
o Qualification of Production Support Equipment.
o Qualification of Clean Utilities.
o Qualification of HVAC (ISO classes 5 to 8).
o Qualification of Control Systems - Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs.
- Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
- Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
Key Competencies Required:
- A degree qualification in science or engineering.
- Excellent interpersonal skills
- Ability to operate as part of a team is critical and also the ability to work alone as required
- Customer focus
- Excellent communication skills
- Attention to detail
- Good problem solving skills
- Results and performance driven