Entreprise:
![](/media/recruiter/recruiter_159/logo-crit-20150615-101223.jpg)
Secteur: recrutement / ressources humaines
Taille: Entre 20 et 100 employés
Acteur global en ressources humaines: recrutement, intérim, formation et conseil RH.
Description de l'annonce:
As the TPM-Supplier QA Manager, you’ll be responsible for:
· Providing QA support for assigned TPM’s and/or Suppliers to ensure that safe, standards and the appropriate market requirements.
· Responsible for development of Quality Improvement Plan for TPMs remediations, when required.
· Managing TPM & Supplier activities while driving continuous improvement for TPMs and Suppliers.
· efficacious, and quality product can be supplied to Abbott FAC to meet cGMP and other applicable regulatory Responsible for Monitoring quality performance for assigned TPMs / suppliers and ensure requirements per Quality Technical Agreements are adhered / followed by assigned TPMs and suppliers
· Leading Quality Technical Agreements approval and renewal
· Primary contact for communication of TPM Quality issues as needed.
· QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, and product release issues as needed.
· Responsible for maintaining regional Approved Supplier Listing.
· Responsible for communication with Global TPM/Supplier QA regarding Global TPM Products that are supplied for FAC (METAP-CIS) region.
· Responsible for supporting Global and Regional Quality Compliance and improvement initiatives.
· Support new contract manufacturing site approvals within METAP-CIS region must approve all new contract manufacturers for EPD commercial product within responsibility.
· QA Lead for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control at TPM and supplier sites
· QA lead for co-ordination with TPMs & Supplier and internal cross functional team as support and interfaces for routine Quality requirements like GMP audits, new projects or initiatives.
· Analyzes data, makes decisions or provides recommendations to senior staff regarding quality related issues & crises. Work cross functionally in identifying and resolving technical issues across different EPD regions.
· Recommends and implements changes to the system as the result of changing regulations and/or business needs.
· Coordinates across functional areas, business units, and/or geographies in order to achieve regional and affiliate goals.
As Product Technology Transfer QA Manager
Act as QA Lead for below quality activities during Product Technology Transfer
· Leading the intiitaion and implaimantion of Change Control / Stability and Change Impact Assessment.
· Test Method Transfer/Analytical Method.
· Validation/Verification.
· Process Validation/Verification Program
· First lot quality review for release the validation batches for commercialization.
· Gather information from the Sending Unit, in order to assemble a data package.
· Evaluate the information gathered and document findings with respect to product robustness.
· Participate to the process of creation, approval and continuous improvement of the regulatory documentation related to EPD products. Provide support for the specification setting to Regulatory Affairs and receiving unit.
· Provide contributions for the Product technical knowledge during and after technology transfer and ensure the product meeting the Quality Standards. Facilitate issue resolution for key investigation and compliance issues
· Involve in support the quality aspects of the Product Portfolio Expansion, Geographic Expansion initiatives NPI (New Product Introduction) and other Non-Centrally Supported Products.
· Ensure that projects and technical activities associated with Drug Substances, Drug Products, Intermediates and non-pharma products (food supplement, medical device, cosmetics) are carried out without business interruptions and according to legal and Abbott Quality, Regulatory and business requirements.
· Liaison between sites QA, commercial affiliates, MS&T (Manufacturing Science and Technology) and other groups as necessary.
· Act as Regional NPI Coordinator for Geo-Expansion, L&A (License and Acquisition) and different project.
· Serve as quality technical resource of regional EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives.
Required Qualifications
· Bachelor’s degree in science , Pharmacy or equivalent level of education at a relevant scientific discipline
· Minimum 5 years of experience in the pharmaceutical manufacturing field (Quality, production, technical support,etc)
· Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations
· Knowledge of international and local quality system and compliance legislations and standards
· GMP/GLP/GCP background related to medicinal products, medical device, food supplement Biotechnological, Biosimilars and Biologics
· Good communication and report writing skills in French, English and Arabic.
· Strong leadership skills in bringing the best out of people, managing work teams and fostering teamwork within the department.
· Strong strategic Planning/ Thinking, decisive judgement, and Implementation skills.
· Flexible for Travel: 20 %
Preferred Qualifications
· Highly skilled on cGMP requirements and Quality Assurance / Quality Control manager for solid and injectable products.
· High capabilities in time management, negotiation skills, multi-tasking, communication skills and Microsoft offices.
· Other qualifications/certifications: IRCA Lead Auditor Certification, Auditor Certification Training, Complaint Certification , GMP-GDP Training. Highly skilled on cGMP requirements, team management, and Quality Assurance / Quality Control manager for solid and injectable products.