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Wörwag Pharma located in Böblingen near Stuttgart is a mid-sized and internationally operating pharmaceutical company. As a family-owned company we develop and distribute biofactors and generics. We are represented in more than 35 countries with about 1000 employees.


Become a part of our team in our headquarter in Böblingen (near Stuttgart) because we are looking for you as a temporary parental leave replacement until 31.01.2023 as soon as possible as

  

Quality Assurance Specialist (m/w/d) Regulatory Compliance 

 

You are the product manager in the compliance team and act as a sparring partner between us and the contract manufacturers.

 

Tasks & Responsibilities: 

 

  • First point of contact for contract manufacturer-specific enquiries and change requests
  • Carrying out compliance checks and deriving appropriate measures and activities
  • Processing of change requests, from the preparation of the request and document procurement to the transfer of the approval-relevant documents and data to the contract manufacturer
  • Reviewing and approving specifications and instructions as well as documents for process validations, analytical method validations and transfers (plans, reports)
  • Contributing your expertise to solve complex regulatory issues to support the regulatory department, e.g. in responding to deficiency letters
  • Participation in projects (product development and optimisation) and technical transfers (change of manufacturer)
  • Optimising and capturing internal company processes between the Quality and Regulatory Affairs departments and creating SOPs

 

Requirements:

 

  • Degree in natural sciences
  • Professional experience of at least 5 years in the pharmaceutical environment, ideally in the area of regulatory compliance as the interface between manufacturing/analytics and regulatory affairs
  • You have experience in quality assurance and have already gained experience in working with the regulatory area; it is an advantage if you are also familiar in dealing with contract manufacturers
  • Sound knowledge of pharmaceutical guidelines (EU guidelines, ICH guidelines, GMP guidelines, AMG, AMWHV etc.) and their application
  • As a team player you like to work interdisciplinary to meet the requirements of our customers and partners
  • You are responsible, have good communication skills, are able to work under pressure and are results-oriented
  • A very good command of English and German rounds off your profile

 

What we offer:

 

  • A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
  • Varied challenges, as well as exciting projects with a strong team spirit
  • Compensation in line with the market and your performance, as well as additional benefits which can be used flexibly according to your needs, e.g.,   
    • Subsidy for direct insurance
    • Individual compensation options for days off, pension provisions or payout
    • Bonago vouchers for special occasions
    • Support for your general well-being and/or work-life balance
    • Health-promoting measures such as discounted conditions on over-the-counter (OTC) pharmacy products or health days
  • Flexible trust-based working hours, as well as the possibility of mobile working
  • Central company headquarters with good public transport connections, as well as mobility allowances
  • A wide range of opportunities for personal and professional development
  • Regular employee events

 

We are looking forward to receiving your application!