Abbott TPM /Supplier QA Manager in Moscow, Russia
Primary Function/Primary Goals/Objectives
The TPM /Supplier QA Manager will provide QA support for Russian Third Party Manufacturers (TPMs) and Suppliers within the EPD Russia organization (including Veropharm), ensuring that safe, efficacious and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.
Key responsibilities will include:
·Implement and maintain QMS for efficient TPM and suppliers handling.
·Drive Continuous Improvement Projects at TPMs & Suppliers to facilitate process efficiencies and compliance adherence.
·Managing assigned regional TPMs & Suppliers from a Quality perspective in order to provide assurance to Abbott that material is manufactured in accordance with GMPs and all relevant license requirements.
Implement and maintain a program/project management process to support quality and compliance initiatives at TPMs and suppliers.
Coordinate DD activities from Russia region QA perspective for BD initiatives including L&A
Coordinate Quality Technical Agreement negotiation and maintenance.
Work with TPMs & suppliers to continually improve Quality systems, including complaints, CAPA, Quality Agreements and PQRs.
Manage complaints and associated investigation for material/purchased from Abbott approved TPMs/suppliers for the region. Co-ordination of activities to support investigations for non-medical and medical (adverse events) complaints.
·Coordinate completion and approval of PQRs (if required) within required time frames.
·Review and approve documentation such as Investigations, Change Controls Validation Protocols as required by TPM’s & suppliers as applicable in a timely and effective manner to assure product release.
·Define and collate value added Quality system metrics that can be used to assess and monitor levels of compliance at the TPM’s.
·Provide co-ordination, support and interfaces with third party manufacturing facilities of new product introduction and transfers.
·Support divisional quality assurance activities in addition to projects associated with products manufactured and distributed by TPMs and suppliers to meet key divisional business goals.
Provide quality support for product transfers (FLTS, FLQR) to/from associated TPMs.
Provide support to affiliates and manufacturing sites for management and oversight of local TPMs/suppliers in the region
The TPM business is critical to the success of EPD. The Quality TPM & supplier organization in the region supports Third Party Manufacturers covering pharma (sterile injectable, sterile liquids, freeze dried, sterile topical, oral solids and liquids, sachets, non-sterile topical and patches) and Active Pharmaceutical Ingredients (API) and all suppliers as approved by EPD QA. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers who provide intermediate/final products to Russia EPD
The TPM & supplier QA organization supports external companies/TPM’s throughout Russia region.
Required: Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology Engineering or other technical/scientific area.
Comprehensive understanding of pharmaceutical manufacturing and distribution for finished dosage forms. Total combined years: 5-8 in QA, Operations or Technical Support in pharmaceutical setting.
Experience of working with suppliers of materials and services, third party manufacturing, contract manufacturing.
Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
Capable of analyzing data in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
Ability to review and assess investigations, ensuring all are appropriately documented with product disposition fully supported.
Other requirements include:
Adaptability, Initiative, Integrity
Planning and Organizing
Ethical behavior & Independence
Ability to prioritize.
Ability to use Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making .
Project management and troubleshooting skills.
Ability to communicate both written and orally, to all levels of management and across different cultural backgrounds.
Knowledge of Russian and international regulations for quality systems and compliance.
TPM /Supplier QA Manager works with guidance from the regional QA Director.
Overall, the TPM /Supplier QA Manager is responsible for ensuring that assigned TPMs and/suppliers maintain compliance with the relevant local and international regulations as required by markets supplied. The Senior Quality Specialist is responsible for ensuring that all of the quality systems are appropriate so that the product safety, efficacy and quality are maintained.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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