BAP Pharma

Quality Manager/Responsible person

Company
BAP Pharma
Location
Höchstädt an der Donau, Bayern
Salary
up to 65000 Euros
Posted
10 Feb 2021
Closes
12 Mar 2021
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations into different countries, with a presence in the UK, USA and Germany.

We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service.  Our culture is one of openness, honesty and respect and our goal is to become the Global Leader in the Clinical Trails Supply Industry, known for our innovation, expertise, ethics and dedication to providing excellent customer services.

We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, without them we will not be able to deliver on our promises.   Our future is exciting, come join us!

Job Description

BAP have an amazing opportunity for a Quality Assurance Manager to join their busy and growing team. Based in Höchstädt Germany, this role is responsible for safeguarding product users against potential hazards arising from poor distribution practices and making sure the company is compliant with EU and German regulations. Must be fluent in English and German

Responsibilities include:-

  • Checking ALL goods received are not counterfeit and have been delivered by bona fide suppliers to a high standard and ensure goods that are damaged are returned or destroyed.
  • Cold rooms, products and warehouse to be maintained at relevant temperatures.
  • Working with BAP’s stock control system and ensure goods are booked in accurately.
  • Meet the conditions of the wholesale dealer’s license and  distribution practices are complied with.
  • Produce weekly stock reports and make sure adequate QP records are maintained.
  • Print weekly orders and report any deviations and understand the workings of various shippers.
  • Ensure that SOPs are up to date and reviewed
  • Liaise with QP for goods arriving from outside the EU, as well as the German Health Authority and be present for any visits.
  • To ensure the company activities are properly reflected in the Wholesale Dealer’s Licence (WDL) and that the provisions of the WDL are observed.
  • Ensure the operations do not compromise quality and ensure an effective quality system is implemented and maintained
  • Ensure that all personnel are trained to carry out their respective duties
  • To ensure full and prompt cooperation with marketing authorisation holders in the event of recalls
  • Oversee audits of the quality system and to carry out independent audits.

Requirements

  • Knowledge of The Medicines Act 1968
  • Knowledge of Eudralex, -The Rules Governing Medicinal Products in the EU, Vol 4
  • Good Manufacturing Practice, -Medicinal Products for Human and Veterinary Use
  • Good Understanding of the Wholesale Dealer’s Licence
  • Understanding of Directive 2001/83/EC
  • Understanding of The New Guidelines for Good Distribution Practice of medicinal products for human use
  • Knowledge of Commission guidelines for GDP of medicinal products for human use
  • Fluent in English and German.

Competencies

  • Attention to detail and thoroughness
  • Concern for standards
  • Excellent communication skills
  • Flexible and adaptable

This role reports to the General Manager. Overtime may be required from time to time to meet project deadlines.  You must be able to sit for extended periods of time and have the ability to work under own initiative and as part of a team.  We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.