CMO Specialist

(Maternity Cover)

Teva

Sofia, Bulgaria

Our Team, Your Impact

As a Quality Analyst you will manage and control the quality (compliance) of local-to-local TEVA bulk products, finished products and packaged products, to ensure they meet the requirements of EU GMP’s, Marketing Authorization Application, National legislation in the dedicated European country, and Teva standards. also, you will monitors supplier performance and supports efforts to develop and implement changes to improve the production process.

How You’ll Spend Your Day

Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality.
Taking actions needed to assure the products quality and compliance. In addition, initiation, coordination, supervision and functional assessment of activities that are carried out by the relevant expert team for this purpose.
Act as internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products.
Provide coordination and controlling of all GMP relevant documents with regard to manufacturing process, quality control and quality assurance.
Collate key quality performance metrics agreed with CMOs & trends.
Support/ perform the initiation, coordination and evaluation of new product introductions and product changes (change control) to ensure projects success.
Perform the QA Due Diligence of New and Existing Contract Manufacturer.
Perform Vendor qualification of local suppliers in collaboration with CQ and TPQ.
Authorization of Master Documents.
Insure that all suppliers in portfolio are audited as per agreed frequency.
Participation in audits and self-inspections.

Your Skills and Experience

You have a degree in Pharmacy, Sciences, Engineering or similar.
You have experiences in pharmaceutical manufacturing/validation or other related experience and in analytical control and regulatory compliance.
It is an advantage if you have working knowledge as quality assurance officer.
Good interpersonal and communication skills as well as organizational skills.
Understanding of the drug manufacturing process and knowledge of generics and branded product development is an advantage.
Ability to communicate complex issues to affected departments, decision making to solve problems.
Able to work independently and manage priorities effectively
Good in written and spoken English.
Proficiency in MS Office, SAP or similar ERP systems
Using Track Wise® or Veeva is an advantage.