Senior Manager Quality Assurance

Senior Manager Quality Assurance

Teva

Troyan, Bulgaria

About the position

This role requires Quality Assurance (QA) oversight of GMP activities: establishment, implementation and maintenance of the Quality Management System in support of Product/Process development, manufacturing, packaging, handling, storage and testing of GMP batches in compliance with the Teva global standards, requirements and applicable regulations.

Main responsibilities

  • Ensures that the research and development (R&D) site procedures and practices are aligned with the applicable regulations and Teva’s global policies and standards;
  • Manages the QA oversight of R&D projects within the Teva Sites and/or 3rd Party Sites;
  • Acts as the QA representative for the team and project meetings, and hosts QA meetings as applicable;
  • Reviews and approves analytical methods/validation/method transfer documentation as well as other documentation needed for NDA/ANDA filings;
  • Reviews and approves initial validation and qualification documentation for utilities, manufacturing/laboratory equipment;
  • Reviews and approves executed batch records and certificate of analyses, stability data and stability related documentation;
  • Acts as the QA representative during technology transfer and new project meetings;
  • Support the development of semi- solid pharmaceutical products;
  • Establishes Key Performance Indicators and provides product status reporting to the site management on product quality and compliance risks with proposed solutions for improvement of the quality and compliance systems;
  • Oversees the R&D supplier management program including evaluation, qualification, approval and change management of suppliers, materials, service providers and other;
  • Ensures that all investigations, CAPAs and change controls reviews requiring QA review/input are complete according to the company policies and procedures;
  • Manages and oversees the site-training program for GMP activities. Conducts trainings for newly implemented or revised procedures;
  • Hosts Regulatory and Teva Global Risk Assessment Audits;
  • Performs internal and external GMP audits.

Main requirements

  • Bachelor degree in Science, Engineering or related field;
  • Master degree in Pharmacy or Chemistry is an advantage;
  • Minimum 10 years of work experience from pharma, preferably in quality assurance environment or an equivalent combination of education and experience;
  • Significant experience in Quality Management, R&D, change and project management;
  • Expert knowledge of regulations (FDA, EMA, ASTM, ANSI);
  • Good understanding of USP/EP methodologies and ICH guidelines;
  • Proven ability to plan resources and manage priorities to consistently deliver on time against tight project deadlines;
  • Ability to work independently and to solve problems;
  • Ability to effectively and clearly communicate in English - both written and verbal;
  • Good computer literacy skills in MS Office package.

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© EuroJobsites 2021

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

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