Company: Edelway Switzerland AG
Location: Basel area
Closing Date: 29 Dec 16
Salary (£): Negotiable
Edelway is a pan-european Pharma Consultancy. One of our best client, a global, pharmaceutical company based in Basel Area is currently looking for experienced Validation Engineer.
- Provide expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing equipment.
- To lead CQV efforts with new equipment and processes from initial specification through to handover for PQ.
- Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
- Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
- Write, review and update the Master Validation Plan and area specific Validation plans.
- Perform IQ, OQ, PQ qualification/validation on processes, equipment and systems in conjunction with suppliers as appropriate.
- Monitor trial, engineering and validation batches to ensure appropriate conditions are met and required samples are taken.
- Co-ordinate delivery of samples to the laboratories and co-ordinate testing of same.
- Co-ordinate shipment of samples, if required.
- Co-ordinate the individual tasks required to validate processes equipment etc.
- Carry out Periodic Reviews of Validated Systems.
- Participate, when required, as a member of multidisciplinary site teams, e.g. Cross Functional Investigation Team.
- Write, review and update Standard Operating Procedures (SOP’s) in accordance with site and corporate requirements.
- Compile and maintain all relevant documentation for submission to management (protocols and reports).
- Attend and contribute to staff meetings and attend appropriate training sessions, as required.
- Comply with the responsibilities as outlined in the Site Safety Statement.
- Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and the clients requirements, policies and procedures.
- Champion safe working practices and safety initiatives within their functional area.
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMP’s and other worldwide regulatory requirements.Problem solving ability and excellent oral and written communications skills.
- Computer knowledge / Word Processing skills.
If this sounds like your next challenge please send us your CV at “email@example.com“ or contact us at +34 93 018 5722.