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Manager Compliance

Date: Mar 13, 2019

Location: Sofia, BG, 1407

Company: Teva Pharmaceuticals

Company Info

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

 

Since August 2016 Actavis has been part of Teva. In Bulgaria the combined company is working under the Actavis brand and is the largest employer in the pharmaceutical industry. Actavis - a Teva company - manages two manufacturing plants, sales and marketing organization and a number of global corporate functions.

 

We are searching qualified and motivated candidates for the position of Manager Compliance, part of Third Party Operations Quality Team, based in Sofia.

The Role:

Manager Compliance will have a sole responsibility of planning, execution and reporting of investigations to find out the root cause of deviation in the laboratory and/ or manufacturing process. He/ she will have to ensure the high quality level of pharmaceuticals products regarding statutory and regulatory requirements and guidelines. Manager Compliance will have to initiate a special expertise as base for decision-making process and CAPA.

Main duties and responsibilities:

Deviation at the quality control

  • Responsibility for assuring that the investigation/deviation is performed according to Teva procedures
  • Identification of critical deviations of validated analytical method, qualified analytical apparatus and preparation of facts for the qualified person
  • Responsibility for coordination of the root cause study in accordance with quality related deviations with the target to prepare a risk assessment and restore the GMP status of the testing process and the field of quality control
  • Initiation and leading of case-related project groups
  • Reconstruction of the deviation and identification of the root cause in accordance with affected departments and/or contract manufacturer
  • Independent categorization of deviations and, if necessary, the decision to put the batches on hold
  • Definition of a CAPA regarding scope, responsibility and time line to determine the source of the deviation and chase the implementation

Deviation at the contract manufacturer

  • Evaluation of deviation reports from contract manufacturer regarding a possible impact of the batch release process in accordance with the QP
  • Responsibility for assuring that all batches were claimed and reservation all its rights that may arise a defect claim, if a manufacturing error was suspected
  • Evaluate the investigation report from the supplier and manage the rejection/ credit note with the Planning Department

Temperature deviation of deliveries to other Teva Sites

  • A risk assessment should be performed according to the stability data
  • Preparation of a deviation report incl. risk assessment
  • Information of the transportation and logistics unit and request of an investigation report from the forwarder

Deviation at the incoming goods department

  • Handling of requests from other Teva sites regarding quantity deviations of the deliveries

Additional responsibilities

  • Participation in customer audits, on-site audits and self-inspection audits
  • Training employees in Track Wise®

Successful candidates should have:

  • Degree in Pharmacy, Sciences, Engineering or similar or at least several years of working knowledge as quality assurance officer
  • Good written and spoken English
  • Experience in pharmaceutical manufacturing, validation or other related experience in analytical control and regulatory compliance
  • Proficiency in MS Office, SAP and Track Wise®
  • 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 considered an advantage
  • Ability to communicate complex issues to affected departments, decision making to solve problems

We Offer:

  • Dynamic and challenging work environment
  • Competitive remuneration bound with performance
  • Opportunity for development in a fast growing international company
  • Job specific training

     

    If this sounds like the right opportunity for you, apply directly online through the button ‘Apply’ and send us your CV in English.

    All personal data is protected by law and will be treated in confidentiality.

Function

Quality

Sub Function

Supplier Quality

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.