Biopharma

Senior Quality Assurance Manager

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About the job

Are you open to an exciting new career challenge?

Invenia Group has partnered with an industry-leading, international pharmaceutical company, looking to hire a Qualified Person/ Senior QA Manager to join its growing team.

Role Responsibilities:

  • Develop and maintain collaborative relationships with the Ministry of Health, the National Health Insurance Fund, the Bulgarian Drug Agency, the Regional Health Inspectorate and other related institutions, as well as contract manufacturing organisations and third-party service providers
  • Adopts SOPs to the local situation and trains local staff, ensuring procedures are kept
  • Organising local risk management plans
  • Performing quality reviews, audits and self-inspections
  • Managing product quality problems/complaints, and reports to HQ Quality Assurance / QP
  • Participate in the preparation and successful completion of first, second and third-party audits
  • Keep up-to-date required licenses for the Company’s core business by current legislation
  • Ensure the business remains compliant with the European and National legislative framework applicable to the products
  • Ensure compliance with the Ordinance of medicinal products, medical devices, food supplements, cosmetics, drugs under control of the law on narcotics, and their order in the warehouse
  • Ensure MAH follows all the necessary processes and procedures to comply with all relevant regulatory requirements
  • Responsible for the management of complaints, returns, suspected falsified medicinal products and medicinal products recall
  • Responsible for the management of the process of destruction of the drugs after expiration. date and/or medicines with quality deviations
  • Provide full Regulatory/ Quality support to the business pharma initiatives and current business
  • Represent the company in front of regulatory authorities
  • Monitor all operations that affect quality
  • Devise procedures to inspect and report quality assurance issues
  • Manage any Quality or Safety issues
  • Contribute to the detection, assessment, recording, understanding, compiling, and reporting of safety-relevant information, as well as risk management activities
  • Organise the acceptance, storage and dispensing of pharma products
  • Control over the quality of goods received at the warehouse and balances, and movement of goods in the warehouse

What we are looking for:

We are looking for a Qualified Person with at least 10 years of experience in Quality Assurance. You should have:

  • Audit experience
  • Experience with all applicable legislations and local regulations
  • Good knowledge of QMS and other associated quality systems
  • Ability to prioritise projects, strong sense of urgency and excellent problem-solving skills
  • Must have excellent interpersonal skills and communication skills, written and oral, in Bulgarian & English

Sound interesting? This is a fantastic opportunity to join a fast-growing company with and recognised best-in-class R&D and manufacturing team with exciting plans. To find out more information regarding this role, please apply.