Quality Control Manager

Quality Control Manager

Teva

Vilnius, Lithuania

Key Responsibilities

  • Manages QC groups’ activities to achieve compliant testing in a timely manner. Schedules and assigns/prioritizes laboratory activities aligned with departmental goals;
  • Provides subject matter assistance for methods, testing, validation and transfer. Manages the method transfer/validation and analytical studies to ensure site suitability;
  • Responsible for CGMP compliance of the laboratory and personnel. Maintains and improves Quality Control GMP compliance and documentation, ensures integrity of QC data;
  • Oversees the effective utilization of QMS by laboratory personnel, develops and maintains compliance metrics and reports to management;
  • Reviews and approves SOP, validation protocols, reports, stability documents, specifications;
  • Evaluates data to ensure compliance with analytical methods, specification criteria, and GMPs;
  • Works with the QC teams to author analytical related deviations, CAPA, OOS and OOT investigations;
  • Provides regulatory/technical guidance as needed;
  • Represents QC during regulatory inspections; Authors/reviews applicable sections of regulatory documents as needed, supports responses to questions from Health Authorities.;
  • Represents Quality Control department in meetings with Production, QA, Engineering, Regulatory Affairs, other related departments or other sites;
  • Interacts with other departments as required to define and/or verify the scope of work for a particular project; i.e. provide testing services for validation work;
  • Ensures the completion of routine activities and projects within budget limits and time projections;
  • Develops and oversee execution of method transfer protocols;
  • Manages performance and development of QC team. Coaches and mentors staff;
  • Demonstrates initiative and motivated to learn new responsibilities.

Qualifications

  • Master’s degree in Microbiology/Biology/Chemistry or related field; with a minimum of 5 years of experience, including 2 or more years of managerial responsibilities in Pharmaceutical industry with emphasis in QC microbiology, QC Analytical, validation and manufacturing processes PhD degree is highly desirable;
  • Behavioural Competencies: Initiative, Personal Leadership, Interpersonal Effectiveness, Productivity, Decision Making;
  • Ability to work with multi-departmental team at various levels in the facility and outside;
  • Advanced problem-solving skills, the ability to think strategically and have sound scientific judgement;
  • Ability to present summaries of discussions and process flows (oral and written);
  • Strong technical and communication skills: oral/written and listening;
  • Comfortable in a fast-paced environment and able to adjust based on changing priorities.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Lithuania     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Teva    

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies