Mes compétences :
Gmp
Quality
Regulatory affairs
Pharmacovigilance
Entreprises
RANBAXY, A Sun Pharma Company
- Pharmacist Responsible, Pharmaceutical Operations Manager
2011 - maintenantPharmacist Responsible, Pharmaceutical Operations Manager – Ranbaxy morocco LLC, a SunPharma Company (Casablanca, Morocco)
Management of diverse departments dealing with different areas of activity related to Pharmaceutical management and technical operations. And assistance of the North Africa Area Manager in all activities in the region.
Drug regulatory affairs management: oversight of all regulatory activities of the local regulatory team. Develops strategies for earliest possible approvals of drug registration in line with the Business development. Ensures appropriate Regulatory support. Management and counsel to the regulatory team. Participating in a higher level interaction with external partners (Moroccan, Algerian and Tunisian authorities and out-sourced agencies).
Market Access: stakeholders mapping, access strategies development according to environment characteristics and products differentiating
Quality Assurance: QP person for release, and handling all the quality activities for the manufacturing site
Supply chain: import activity, sales order management, manufacturing scheduling and inputs ordering
Manufacturing & Toll- manufacturing: plant management and KPI’s follow up, contract & services negotiation
Marketing: Marketing supporting: review of the promotional Inputs and support of the marketing team
Medical and Drug Safety and Pharmacovigilance: safety assessment of products throughout their lifecycle and oversight of global drug safety processes in conjunction with the Company’s development and commercial objectives. leading the pre- and post-marketing safety, PV and risk management activities
Tender supply: tender submission and price fixation
Member of the Board committee of the Company
SOTHEMA
- Responsable Assurance Qualité
Casablanca2004 - 2011* Validation activities:
Expertise in validation, complete familiarity with International standards (CFR and Eudralex), GMP and Regulatory.
Management of validations related to continuous validation and request of process change activities of commercial manufacturing units, covers facility, systems, equipment Qualification ( IQ, OQ, PQ) and Process Validation (PV).
Responsible to establish the validation policies and standard processes covering continuous validation activities (annual validation plans and qualification plans associated to Changes) and assure the associated coaching and harmonized implementation on site.
* Documentation & batch release:
Make routine go/no go decisions regarding routine product release. Perform final batch disposition steps.
Review and approve validation and equipment qualification protocols and report in collaboration with the engineering department.
Author, review, revise, and approve Standard Operating Procedures (SOP’s)
*Audit & inspection:
Interact directly with Regulatory Agency during on-site inspections.
Plan and execute the performance of internal audits and inspections. Ensure continuous GMP, regulatory compliance through audits of all GMP processes.
Trend and analyze audit findings; provide results to customers.
* Other activities:
Responsible to coordinate the establishment of template for the writing of the facility submission files. Coordinate submission activities with Regulatory Affairs.
Coordinate the metrology activities.
Lead the training operations.
PFIZER
- Chargé de projets Qualité
Paris2003 - 2004Implementation of a management system of training and habilitation of the quality control technician and the industrial pharmaceutical support in accordance with the regulatory requirements (GMP, internal policies PQS: Pfizer Quality Standards).
Reviewing of the documentation system within the ISO requirements and the process approach.
Implementation of “Documentum®” electronic system management of documentation and preparation of the validation of the computer system (workflow and electronic signature).
