Quality Compliance Officer - GDP

Norgine

Rueil-Malmaison or Dreux, France

The person holding this position will report to the Quality Compliance Manager.

The Quality Compliance Officer is responsible for providing support to the Regional cluster France & BeNeLux with regards to Good Distribution Practice (GDP) and product compliance related activities.

RESPONSIBILITIES

Ensure that Norgine’s regional clusters quality management systems is maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.
Act in a capacity on behalf of Norgine’s regional cluster to performed delegated duties concerning regional Wholesale Distribution licences, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on GDP of medicinal products for human use and in accordance with the French regulation article R.5124-2 du Code of Public health.
Perform the process of batch release for the national administrative releases of product to market once received from the manufacturer and prior to distribution.
Ensure the batches follow up and declaration of shortage or risk of shortage for Major Therapeutic interest to relevant stakeholders.
Generate regional metrics that deliver a clear understanding of the levels of compliance through the distribution network, to responsible management. Identifying noncompliance and associated risks and contribute to risk reduction strategies with clearly communicated action plans.
Act in a capacity on behalf of Norgine NV as Responsible Person (RP) for GDP on the Norgine NV (NNV) Wholesale Distribution license, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use and the Belgian Royal Decree of 14-12/2006 art.94 – 10.
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Requirements

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 medical device industries, in particular the pharmaceutical distribution environment with good knowledge of GMP/GDP.
Excellent influencing skills and ability to establish effective working relationships with personnel at Norgine or distribution partners.
Excellent verbal and written communication skills ability to present effectively to groups.
Proven ability to use Quality Management Systems and KPI reporting to best advantage in support of compliance and continuous improvement.
Proven ability to make science based, data driven recommendation/decisions and take appropriate action.