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Job Details

BELGIUM: QA Product Complaints & CAPAs Manager EMEA ** Small team ** Co-lead new system rollout ** Relo offered!

Company: Advanced Regulatory (UK & Europe)
Location: BELGIUM
Reference: MGADV / 45728/A
Closing Date: 29 Jan 18
Type: Full Time
Salary (£): On Application
Benefits: On Application

Job Summary:

If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3386.

Requirements:

QA Product Complaints & CAPAs Manager EMEA ** Supervise a small team ** Co-lead a new system implementation ** Develop metrics & reporting ** Close out CAPAs with Contract Vendors *** BELGIUM: GHENT / ANTWERP 

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This is a fast moving and dynamic company, growing rapidly in the EMEA region and world-wide by over 10% a year with a mix of solid dose (SD) and other dosage forms, now building a central Quality function supporting principally the EU and MENA region plus some other markets world-wide with a CMO/Vendor model.

Reporting to the QP and Quality Lead, my role will appeal to an experienced GMP Quality Professional who has experience in product complaints and CAPAs ideally for SD, ideally in the EU or extended EU region, or a major affiliate, who now wants to lead a small team of 3 and gain more experience, ie continue to work on solid dose but gain more medical device product experience and lead your own team:-

  • To work with subject matter experts and suppliers to ensure effective investigation and root cause analysis and CAPA for short term and long-term improvements; manage identified Remediations out to Vendors and CMOs to satisfactory closeout
  • To be the single point of accountability in for logging, co-ordination of investigation with suppliers and responding to complaints and to manage the team to achieve this in a timely, compliant manner (current levels approx. 5000 per year across all product categories)
  • To work closely with own team to ensure better compliance, quicker turnarounds and patient / customer satisfaction
  • To work closely with product safety teams and participate in safety review meetings as required
  • To use knowledge, experience, education and training to identify individual serious complaints that may result in market action or similar and to ensure adverse event complaints are identified and handed to safety group for evaluation and regulatory reporting.  
  • To design and implement key performance indicators to verify efficiency and effectiveness of processes and procedures to agreed standards
  • To support the implementation of a new IT system to allow better workflow for complaint tracking, trending, reporting
  • To create management reports which give clear indication of adverse trends and to formally communicate these to affiliate markets, suppliers and management as required
  • To support creation of frequent Q & As for affiliate first point of contact.

To apply for this role you must be eligible to work in the EEA, and also have:-

  • Life Sciences degree, such as Pharmacy or Chemistry or Industrial / Chem Engineering; speak English to an business level
  • Living in Belgium or be willing to relocate to Belgium (and be eligible for this)
  • Have experience in QA customer incidents and complaints as well as CAPAs
  • Have knowledge ideally of Solid Dose forms, or have experience in Medical Devices, and want to gain the other category
  • Any experience in ISO standards is favourable
  • Has either the personality or experience to be engaging, likeable and useful to your team members and the company as a whole; previous supervisory experience is useful.

My client is offering relocation from the EU region, as well as a decent and competitive package of between 55-85K per annum and a 10% bonus, and full support for moving if required.

______________________________________________________________________________________________

If you wish to apply for this role, please send your CV with a covering note to cv@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on +44 (0)20 7801 3380.
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About Advanced

Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland.

We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com.

Keywords / Key words: Quality Assurance Jobs, Jobs in QA, Jobs in QA and CAPAs, Customer Complaints, CAPA Manager, Pharmaceutical Jobs in Belgium, QA jobs in Belgium.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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