Вакансія QA Manager CIS Third Party Manufacturing & Supplier

Main responsibilities:

• Responsible for routine activities of Quality management for TPM and Supplier in the CIS region, for delivering quality products through reliable supply chain.
• To support TPMs and suppliers for implementing effective quality systems to maintain compliance.
• Responsible for Monitoring TPM quality performance for TPM and Supplier in the CIS region.
• Responsible for review and maintenance of Quality Technical Agreements for TPM and Supplier in the CIS region
• Contact for communication of TPM Quality issues as needed for TPM and Supplier in the CIS region
• QA support for investigations, trends, complaints, corrective and preventive actions (CAPA), validation support, product release issues, PQR review and change control as needed.
• Provide co-ordination, support and interfaces with third party manufacturing facilities for new product introduction and transfers for TPM and Supplier in the CIS region.
• Responsible for updation and maintenance of regional approved supplier listing for TPM and Supplier in the CIS region.

Experience:

• Preferably an Engineer degree in Chemistry, Chemist, or Pharmacist with at least 5 years experience in a combination of the following areas: manufacturing, materials management & logistics, QA/QC, knowledge in TPM (Third Party Manufacturing) in Pharmaceutical industry.
• Experience in Production is highly recommended.
• Knowledge about Technology Transfer (Process validation, stability and batch documentation review ).
• Knowledge of regulatory and compliance requirements in relationship to manufacturing and contracts.
• The individual will have demonstrated success in financial analysis, negotiations, and project management.
• Good organizational skills, Experience in CIS Region is preferred.
• Excellent communication both written and verbal at a local and international level, tact and diplomacy are critical to the performance of position requirements.
• Knowledge and experience in working in a cGMP environment.
• Fluent in Russian and English.
• Ability to travel with in or out of the Country.
• Strong analytical thinking, result oriented, negotiation and decision making skills.
• Stress resistance.