Quality Compliance Officer - Gdp H/F Norgine

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

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MAIN TASKS

- Ensure that Norgine regional cluster quality management systems is maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.
- Keeping appropriate records of any delegated duties and activities
- Act in capacity on behalf of regional affiliate network cluster to performed delegated duties concerning regional WDA licences.
- Ensuring that suppliers and customers are approved
- In case a recall for medicinal products is deemed necessary, promptly perform any necessary operation for the regional cluster
- Ensuring that initial and continuous training programs are maintained to assure competency in GDP for the regional cluster
- Ensuring that self-inspections are performed at appropriate relevant intervals following a pre-arranged programme, participate in GDP self-inspections for regional clusters and ensure necessary corrective measures are put in place
- Support the data generation and perform for the quality management reviews
- Participate in Regional Inspection readiness activities to ensure adherence to the applicable internal and external standards of compliance at all time.
- Participate and support external competent authority inspections alongside RP/GDP affiliate teams
- Development/management of quality documents and key performance indicators
- Approving any subcontracted activities which may impact on GDP
- Ensuring that any additional requirements imposed on certain products within regional cluster by national law are adhered to
- Archiving GDP Information following records retention procedures
- Support RP/GDP Affiliate quality teams to ensure RP responsibilities are upheld
- Assist in revision /administration of local SOPs, WI, Forms and templates regarding GDP activities.
- Ensuring that relevant customer complaints are dealt with effectively including recording of complaints and sharing with manufacturing sites
- Deviation, CAPA and Change Control Management.
- Management of drug shortages.
- Support the process of batch documentation for the national administrative releases of product to market once received from the manufacturer and prior to distribution
- Prepare documentation, update trackers, check batch documentation and communicate appropriately internally and externally.
- Ensure compliance to Good Distribution Practice and French regulations of Batch management and follow up :
- Perform batch release process for the national administrative releases of product to market in accordance with the delegation from the national responsible Pharmacist.
- Prepare documentation, update trackers, check batch documentation and communicate appropriately internally and externally.
- In case a recall for medicinal products is deemed necessary, promptly perform any necessary operation for the regional cluster.
- Management of quality complaints related to marketed drugs by Norgine (operational activity of processing, follow-up according to procedures and sharing with manufacturing sites).
- Approval and signature of drug destruction requests prepared by the distribution and customer service department in accordance with the delegation from the national responsible Pharmacist.
- Management of drug shortages : ensure batches follow up, declaration of shortage risk and effective shortage on major therapeutic interest.
- Verify and approve the return in accordance with internal process.

EXPERIENCE

- Pharmacist Degree with a professional qualification and RP status would be essential.

- Relevant pharmaceutical industry experience.

- Experienced in supporting successful regulatory inspections.

- Good knowledge of regulatory requirements impacting the pharmaceutical and medica