QUALITY MANAGER
MAIN TASKS:
- Ensure that all processes needed for QMS are established, implemented, maintained and documented in accordance with corporate requirements
- Lead the development and implementation of Quality Manual and QM procedures;
- Set up and maintain QM documentation system, ensure regular update and review of quality documentation;
- Establish and maintain records to provide evidence that QMS is followed;
- Monitor the performance of QMS, identify non-conformity cases and areas for improvement, provide reporting to management, initiate improvement measures;Ensure that quality objectives and KPIs are set and reviewed on a regular basis;
- Organize and supervise preparation for internal and external audits, analyze audit results, design CAPA plans and monitor adherence;
- Plan internal audit schedule, lead the team of internal auditors, ensure that audits are performed and documented according to the plan and in line with corporate requirements, ensure successful completion of corporate audits.
- Perform external audits during vendor selection process in Russia & CIS countries: : CMO, WH service providers, other service providers (PV, registration services);
- Support GMP and QMS inspections on country and regional levels;
- Ensure compliance with ISO certification requirements, manage ISO certification, liaise with external bodies and Global Quality Organization on all certification-related matters;
- Provide advice and expertise on all QMS-related topics, train personnel in QMS;
- Handle and respond to customer complaints with regard to product quality (medicines, medical devices & enteral nutrition products);
- Support /ADR and incident process management (investigations, actions, communication with Healthcare Authorities);
- Monitor legislation in QA area in Russia & CIS countries, advice management accordingly.
SECONDARY TASKS:
- Act as responsible person for local release back-up (Deputy);
- Support registration projects in aspects related ND (specifications and methods verification in EAEU countries);
- Support selective control process for medicines in Russia, for medicines and medical devices in Kazakhstan;
- Support purchase of standards, reagents and materials;
- Communicate with Russian State Laboratories on topics related to medicines specification control, selective control procedure.
QUALIFICATION AND EXPERIENCE:
- Higher education: degree in Pharmacy (preferrable) or Biochemistry;
- 5+ years of experience as Quality Manager in international companies (preferably pharmaceutical, MD, food production, FMCGcompanies);
- Strong experience in and proven track-record of implementing and maintaining QMS (SOPs development, QMS documentation system, quality audits);
- Experience in and proven track-record of ISO certification would be a great plus ;
- Knowledge of ISO 9001, certificates in QM would be a great advantage ;
- Good working knowledge of English;
- Willingness to develop and gain new skills.