Senior QA Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. Germany
Munich, Germany
Posting date: 07 Apr 2021

An innovative pharmaceutical company is in search for a talented QA Specialist, this is a senior role and the selected candidate implement product monitoring, address product recall and product complaints.

Job Responsibilities

  • Implement Product Monitoring, Product Recall, Product Complaints, etc. in time for commercial production
  • Reviews and approves controlled documents for GMP compliance, such as master batch records, test methods, trend reports and product specifications.
  • Make batch disposition recommendations to the Qualified Person based on reviews of executed batch records, non-conformance events (e.g. out-of-specifications of raw materials or drug substance) and supporting data.
  • Lead complex deviation investigations and collaborate with technical teams and external contacts to align compliance expectations and support follow up actions.
  • Use basic project management tools to track actions and timelines.
  • Interface with regulatory agencies, suppliers, service providers, and executive management * QA approver for major change controls , deviations and CAPAs; ensure timely investigation and/or
  • implementation, review, approva and closure
  • May directly manage 1 2 QA specialists with long term opportunity for expanded managing role

Skills and Requirements

  • 8 year s experience in a GMP regulated work environment (particularly Quality Assur ance) with solid understanding of EU regulations , aseptic filling experience preferred
  • Bachelor or higher education level, major ed in bio pharmaceutical or related discipline (including
  • bio technology, pharmacy, chemistry. etc)
  • Ability to work as part of a high performing team and collaborate effectively with staff at all levels
  • Results oriented and ability to deliver under pressure in a fast paced environment
  • Skilled at assessing priorities and successfully managing workload with minimal supervision
  • Solid oral and writing proficiency in English language , German language is a plus
  • Demonstrated strong interpersonal, communication and leadership skills (wit h or without direct reports)
  • Proven track record of contributions and professional growth and development in prior roles, including ability to apply judgment to areas outside of core competency

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.