Project Manager Cleanrooms (Suffolk)Project Manager / PM / Project Engineer NewmarketWorking for a small but leading specialist in cleanroom technology, this is an opportunity for...
QA & Validation Leader - Pharma - Cambridge/Newmarket/Bury St Edmunds - Circa £35k DOE
My client is a leading pharmaceutical company globally and they are looking for experience Quality & Validation professionals from a pharmaceutical or medical device background to join their organisation on a permanent basis. They are currently looking for a technical specialist and a supervisor to join their department and the company offers excellent scope for development. If you are interested in hearing more about this opportunity apply now via the website or call Joseph Tiffin on 0161 868 2214 for more information.
- Maintain a local change control process to ensure all changes are fully documented
- Ensuring all changes are assessed for risk and impact prior to implementation
- Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
- Management of the site Validation Master Plan
- Ensuring all equipment used for the manufacture and storage of product is validated before use
- Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.
- GMP and Facilities and Equipment Control
- Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
- Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete
- Investigation of out of limits results using exception and CAPA processes
- Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
- Quality System Measurement and Review
- Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
- Corrective and Preventative Action
- CAPA owner and leader
- Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames
- Degree qualified in a relevant Engineering or scientific discipline
- Experienced working in the pharmaceutical industry ideally in a sterile or aseptic environment
- Experienced in reviewing and executing CAPA's
- Experience in validation processes a familiar with Validation Master plans
- Experience ensuring equipment is fully compliant with Quality and validation regulatory requirements
If you believe you meet the requirements and you are interested in hearing more about the role apply now via the website or call Joseph Tiffin on 0161 868 2214.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.