CMO Specialist (Maternity Cover)

Description

About the job

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

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.
  
  

How We’ll Take Care Of You

• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance and additional flexible benefits
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development
  
  

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.