Skip to main content

This job has expired

Senior QA Specialist

Employer
Proclinical Staffing
Location
Germany, Munich, Bayern
Salary
Negotiable
Start date
7 Apr 2021
Closing date
21 Apr 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

#LI-AM1

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert