Compliance and Regulatory Lead
Il y a 3 mois
**Mission of function**
Production of bipharmaceuticals products conform to the requirements of international quality defined by FDA, EMEA, ICH, etc.
Quality Project Lead is the single point of contact for all requests linked to operational quality assurance related to products. His/Her main responsabilities are:
- Quality management of product and the follow up with client
- Activities oversight in agreement with applicable laws
RA specialist is the link of the pharmaceutical company with current rules related to laws and regulations.
Be a QP in order to act as a QP delegate is an asset for this role.
**Contexte of position and function**
This type of facility needs to be conformed to the rules and regulation of the cGMP established by the ministers of health and the social protection of countries, as well as the international directives.
The production activities need to be executed in an effective and efficient way to guarantee the global competivity of the sites. Besides, due to the very high value of the products, the activities need to be executed in a highly controlled way.
**Content of the function**
**Principal axis of responsibilities**
- ** Quality reference**
Bring quality expertise for contracts discussions Be active part of the kick off meeting for each project Be the single point of contact for client and project manager (from master cell/virla banks to filling step) Define quality requirements related to project Drive review of Quality Agreement (QTA) Be part of meetings where needed (client and/or internal) Help and approve procedure linked to projects Approval of product specifications Approval of stability protocols and reports Approval of master batch record Approval all documents written by life sciences department Approval of devaitions and OOS related to the projects Approval of CAPA and change control linked to projects
- ** Regulatory**
Conduct regular close surveillance of the health regulatory environment, digesting & disseminating information and assisting in its implementation, coupled with increasing own overall regulatory knowledge (personal, quality, site) via training & communication tools development. Capture opportunities to offer regulatory services as part of our integrated offering concept based upon site, product & process knowledge, in order to optimise our customers’ product registration path by:
- Providing project regulatory liaison,
- Providing counselling on related regulatory matters,
- Defining regulatory strategies to the latest standards,
- Authoring and reviewing CMC/ CTD M3-Quality documents (IND-IMPD, BLA-MAA) for EU, USA and RoW markets,
- Performing life-cycle management activities (post approval changes, deficiency letters/ questions from authorities, etc.), and
- Tracking regulatory deliverables, such as invoices, together with business & finance partners for reporting purposes.
From a site perspective:
- Assume responsibility for the maintenance of all official authorisations, domestic as well as foreign, including legal aspects (FAHMP manufacturing licence & GMP certificates, FDA e-establishment registration, JP accreditation, etc.),
- Supervise the life-cycling of the Site Master File (SMF) and the type V DMF,
- Support customer audits and regulatory inspections and preparedness, as required
From a product perspective:
- Assume responsibility for building-up and & maintaining customers’ product registration information database for translation into Production and Quality Control master documents
- Address feasibility studies for New product Introduction,
- Collaborate on components database accuracy and needs per evolving regulation by partnering with site QC (e.g. TSE, Elemental Impurities, Nitrosamines, etc ),
- Participate in the site’s Change Control process by defining regulatory requirements,
- Design necessary regulatory systems & SOPs and thereby ensure relevant document archiving.
Ensure adherence to regional key deliverables plan, in particular on quarterly indicators mirroring regulatory metrics per annual goals, for Global RA reporting:
- Regulatory services and associated revenue,
- Regulatory compliance activities figures, and
- Worldwide product commercial approvals.
- ** QP delegation**
Final disposition of the product taking into account reviews of (non exhaustive)
- Executed Batch Record
- Events (devaitions, OOS,..)
- Change controls
- Products specifications
- Clients contracts
- Regulatory compliance to the market
Par delegation de la personne qualifiee de l'entreprise, le delegue QP doit s'assurer que:
- Chaque lot de produit fini doit être confirme par une personne qualifiee au sein de la CE/EEE avant d'être envoye/expedie.
- Les principes et les lignes directrices des BPF tels qu'enonces dans la Directive 2003/94/CE relative aux medicaments et aux medicaments experimentaux à usage humain, tels qu'interpretes dans le Guide des BPF de la CE, ont ete suivis.
- La conformite à l'arrête royal belge
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