Qualified Person - S

Employer
CROMSOURCE
Location
Germany
Salary
Competitive
Closing date
17 Sep 2020

View more

Discipline
Quality, Qualified Person
Hours
Full Time
Contract Type
Permanent
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Description:
Job Title: Qualified Person

Location: Stuttgart, Germany

FTE: 1.00 - Office based

Start Date: As soon as possible

TalentSource Life Sciences is currently recruiting for a permanent Qualified Person (QP) to join the team of one of our clients as a permanent employee. This client is a dynamic and international company, characterized by innovation and a culture that puts the patient at the center.

Scope of the role:

You are responsible for ensuring the quality of the medicines manufactured in the area of responsibility and their release for use in clinical trials.

Main Job Tasks and Responsibilities
  • Certification of drug batches as a knowledgeable person
  • Participation in the development, production, testing and approval of medicinal products as a QP in accordance with §§ 13, 15 Medicinal Products Act
  • Information and advice to employees, physicians and other healthcare stakeholders through product risk assessment of drugs
  • Keeping a continuous register of all released batches in accordance with § 19 Medicinal Products Act in conjunction with § 17 Medicinal Products Act
  • Final evaluation and approval of deviations and complaints
  • Auditing of manufacturing and testing facilities
  • Ensuring the proper retention of restitution patterns
  • Participation in the supervision of customer audits and official inspections


Education and Experience
  • Pharmacist with approbation as a pharmacist or comparable
  • Suitability for designation as QP according to Medicinal Products Act §15 (1) and (4)
  • Ideally, experience with clinical investigational medicinal products
  • Several years of professional experience in the GMP-regulated environment
  • Work experience in quality assurance as well as audit experience desired
  • Assertive personality
  • Flexibility and resilience
  • Team Player
  • Fluent German and English spoken and written


The Benefits of Working for our Client
  • Challenging tasks in a dynamic and international environment
  • Professional support during training
  • Tariff package of the chemical industry and location-related additional social benefits


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001976

If you would like to discuss the role before applying through the website, please contact alexander.sourounis@cromsource.com for more information.

Who are CROMSOURCE:

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

By joining our client teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Qualified Person, QP, Manufacturing, GMP, Audit, Quality Assurance

Skills: Qualified Person Location: Germany Share:

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CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Contact Us
  • 6-9 The Square
  • Stockley Park
  • Hayes
  • UB11 1FW
  • United Kingdom
  • +44 (0) 1786 468990
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