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.