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- Leading Pharmaceuticals Manufacturer
- Growing Company
About Our Client
This Cambridgeshire based company are growing significantly & want to ensure that Quality remains an integral part of all that they do. As the Qualified Person on site you will be responsible for the release of batches. With excellent positioning in the market place, you have the chance to be part of their exciting journey.
As the Qualified Person you will be ensuring that products are fit for their intended use, that they comply with the requirements of the relevant Manufacturing License, the Marketing Authorisation & do not place patients at risk due to inadequate safety, quality and efficacy.
Key Responsibilities Include:
- To ensure processes have been carried out in accordance with Good Manufacturing Practice and Good Distribution Practice.
- To ensure the batch and its manufacture comply with the provisions of the marketing authorisation (including the authorisation required for importation).
- Day to day Batch release activities.
- Ensure GMP and GDP compliance at site.
- To ensure that the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
- To check if any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system.
- To verify that the all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
- To verify that all audits have been carried out as required by the quality assurance system, and extend support to team when required.
- Review and implement QMS and keep up to date with current GMP and any regulatory update or observation.
- Maintains product quality and release by enforcing quality assurance policies and procedures and GMP requirements.
- Investigation of complaints and initiating corrective & preventive actions.
- Reviewing SOPs and updating documents.
- Perform audits of API sites, Contract Testing Laboratory, Release site, Affiliates and Warehouse in UK and Europe and ensure recommendations are complied with.
- Perform self-inspection and ensure compliance.
- To maintain knowledge of current guidelines and GMPs in line with duty for continual professional development.
- Completion of MHRA or other audits to required standard, no critical or major observations.
- Adhered to department metrics at all times.
The Successful Applicant
A Qualified Person with Pharmaceuticals manufacturing experience & the following:
- A relevant degree qualification (preferably in Chemistry, Pharmacy or Biological Science.)
- Up to date knowledge of cGMP, cGDP and HSE.
- A good track record with the FDA, MHRA, EMEA and other regulatory agencies.
- Substantial previous Quality Assurance experience.
- Excellent communication skills
What's on Offer
Circa £75,000 - £85,000 + Benefits