Senior Quality Assurance Specialist, Belgium, L

Employer
CROMSOURCE
Location
Geel, Belgium
Salary
Competitive Salary
Start date
30 May 2022
Closing date
29 Jun 2022

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details

TalentSource Life Sciences, the CROMSOURCE flexible resourcing department, is currently working with one of our partner sponsors to hire a Senior Quality Assurance Specialist to join their team as their permanent employee.

Main Job Tasks and Responsibilities:

  • This position will be reporting to the External Quality (EQ) Manager/Senior Manager. This position provides support to EQ Managers/Senior managers regarding Quality Assurance, Compliance, and Technical Support for external manufacturers. Provides QA support for technology transfer, PPQ, NPI introduction, and improvement of existing manufacturing processes
  • Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of client products at external manufacturers. Ensures proactive and continuous compliance with applicable Health Authority regulations standards, including effective risk management.
  • Conducts batch record review, and investigations perform audits, collects data, analyzes trends, and prepares reports as required. To provide support to EQ manager/senior manager on data collection during Escalation of any major/critical issues as appropriate and provide support to EQ manager/senior manager during the Management Reviews.
  • Works closely with EQ Manager/Senior Managers and other internal functions (PES, TO, EHS, and Procurement, etc.), other Quality Assurance functions, and external manufacturers.
  • Live Our Credo & Pursue Our Purpose:
  • Pursues high standards of quality and compliance. Consistently makes Credo based decisions to take actions that prioritize customer, patient, and employee needs
  • Provides support to EQ Manager/Senior Manager to ensure the success of external manufacturer qualification and monitoring, with an emphasis on continuous improvement, global alignment, risk management, and supply chain reliability. Provides balanced management of quality and compliance risks with business needs
  • Provides support to EQ manager/senior manager to ensure effectuate and permanently maintain inspection readiness at the external manufacturers, including on-site representation during regulatory inspections and audits. And support EQ manager/senior manager to drive the development of corrective actions plans, as needed.
  • To support EQ account owner on the quality and reliability of products produced at the external manufacturer. This role will support the EQ account owner in the continuous oversight and management of:
  • Quality activities during manufacturing and quality control (including validations, issue management, troubleshooting, change management, supplier, and material management)
  • Execution of monitoring and auditing activities (including the creation of quality agreements)
  • Assessing quality systems and recommending improvements to enhance quality
  • Reporting of quality activities, and as the needed escalation of issues to senior JSC management
  • Develops self to reach their goals. Engages in open and honest conversations. Drives performance by managing energy and taking ownership for outcomes
  • To support EQ manager/senior manager in the execution of quality activities such as New Product Introduction (through upscaling and launch), process improvements, and significant changes.
  • To support EQ Manager/Senior Manager to ensure alignment of supplier qualification/monitoring activities with the strategic business direction.
  • To support EQ Manager/Senior Manager to ensure that the quality process and systems to support Janssen product manufacturing are adhered to and maintained. Communicates expertise and guidance on relevant regulations, directives, J&J standards, and industry guidance related to quality systems design and operation.
  • Support EQ Manager/Senior Manager on frequent interactions with external manufacturers, for the purpose of driving reliability, continuous improvement, Risk management, Quality strategies, and Quality System compliance.
  • Communicates external manufacturer status to EQ Manager/senior manager.
  • Under the supervision of EQ Manager/Senior Manager, this role might need to connect with other Quartet functions (PES, TO, Planning, etc.).
  • Remaining current with local, regional and global Health Authority regulations, guidelines, and quality practices associated with cGMP and API manufacturing.

Education and Experience:

  • Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Process technology / Chemical Engineering Required. Advanced degree (MS is preferred. 6-10 years of experience in the Pharmaceutical or Biotechnology cGMP environment is required.
  • Experience in API, drugs or biologics quality management or
    manufacturing is essential to success. Experience in External Manufacturing, Technology Transfers, Quality Event Management, and Quality System Development will be a plus
  • Experience in presenting issues to all levels of the organization will be a plus

Specific Role Requirements and Skills:

  • The ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required. Including proven ability to support Regulatory inspections and Heath Authority exposure
  • Demonstrated experience with API manufacturing and Quality control is preferred. Including understanding of typical unit operations, process equipment, and analytical techniques (HPLC, GC, IR, wet chemistry testing, …)
  • Demonstrated experience with quality activities during API process development, upscaling, validation, and launch is preferred. Including understanding of filing requirements and regulatory support.
    Proficiency in computer applications such as the MS Office suite is preferred.
  • Interpersonal skills are required to build long-term relationships, influence up and down, negotiate acceptable outcomes, and multiple disciplinary, cross-cultural environments in External Manufacturers. This will be a plus
  • Demonstrates refined skills in the following Leadership areas: Integrity and Credo-based Actions; Collaboration and Teaming; Sense of Urgency; Results and Performance-Driven. Ability to travel a minimum of 5-10% is required. The position will be based in Belgium
  • Fluent in English
  • QA background

The Benefits of Working for our Client

  • Competitive Salary 
  • Group and hospitalisation insurance 
  • Electronic meal vouchers 
  • Internet reimbursement 
  • Dedicated Line Manager  
  • Regular face-to-face or phone meetings with the line manager  
  • Full annual performance review process  
  • Ad-hoc team events and end of year party 
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally 
  • Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process:

Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/jobs please contact careers@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 are 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.   

Keywords: QA, Senior QA, Senior Quality Assurance Specialist, CRO, Clinic Research Organisation, Pharma, Biopharma.

Skills: Quality Assurance Manager, CRO, Quality Assurance Location: Belgium

Company

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.

Find Us
Website
Telephone
+44 (0) 1786 468990
Location
6-9 The Square
Stockley Park
Hayes
Uxbridge
UB11 1FW
GB
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