Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Quality Specialist - GMP

Company: CROMSOURCE
Location: Belgium
Reference: HQ00001213
Closing Date: 25 Mar 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Job Title: Quality Specialist - GMP   Location: Braine L'Alleud, Belgium   TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Quality Specialist - GMP for one of our partner Biopharmaceutical Companies. This is a permanent position with TalentSource. The successful candidate will be working on studies dedicated to one client.

Requirements:

Job Title: Quality Specialist - GMP

Location: Braine L'Alleud, Belgium

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Quality Specialist - GMP for one of our partner Biopharmaceutical Companies.

This is a permanent position with TalentSource. The successful candidate will be working on studies dedicated to one client. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

You will be placed in a Quality Assurance team to provide maintenance of a desired level of quality in product related project activities products that are externally manufactured.

Main Job Tasks and Responsibilities:

  • Provide support to the Global (Product) Quality Leads
  • Support Regulatory Submissions and coordinate related activities
  • Product Quality Evaluations
  • Prepare, manage, distribute product related documents
  • Maintain Product cockpits and data
  • Collect, analyse and report Product metrics including Trackwise metrics
  • Maintain Product chain overview and prepare / maintain of flows
  • Support preparation of Product Quality Review (PQR) Executive summary reports, tracking of individual PQRs, link with QC, data extraction, etc.
  • Prepare Product change control committees and Product market complaints committees
  • Preparation of inspections, management review

Education:

  • University Degree in life science - required BA, preferred MS

Minimum Work Experience:

  • Significant experience in working in the pharmaceutical biologics industry
  • Must have a profound knowledge and understanding of Quality management and operational GMP experience.
  • Experience interacting with regulatory bodies and third party organizations with respect to QA systems and regulatory inspection preparedness

Skills:

  • Pharmaceutical technical understanding and expertise enabling to review and judge upon technical documents related to manufacturing and analytical testing
  • Knowledge and understanding of Quality management
  • Operational experience and knowledge of Europe and/or US GMP
  • Experience interacting with regulatory bodies and third party organizations with respect to QA systems and regulatory inspection preparedness
  • Fluent English language, additional welcome French language skills
  • Excellent interpersonal skills
  • Ability to work ina matrix and a multi-cultural environment
  • Capacity to extract data from Trackwise system and further data handling in Excel
  • Aptitude for prepare PowerPoint presentations

Our benefits when working via TalentSource Life Sciences in Belgium

  • Dedicated Line Manager
  • Employee satisfaction survey - your feedback is important for continuous improvement
  • Annual appraisals development planning
  • Yearly team event
  • New Year's diner
  • Group- and Hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company mobile phone
  • Car with fuel card

If you have the experience needed for this position, please contact Laura Guascone, Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to Laura.Guascone@cromsource.com.

Why TalentSource Life Sciences/CROMSOURCE

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords - Quality Specialist, Quality, Quality Assurance, QA, GMP, Good Manufacturing Practice, Quality Management, Quality Manager, Outsourced, Pharma, Pharmaceutical, Contracts, Contract, CRO, Contract Research Organisation, Trackwise

Quality Assurance

Apply for this job: Quality Specialist - GMP

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.