Senior QA Specialist

Location Geel
Discipline: Pharmaceutical
Job type: Temporary/Freelance
Contact name: Isla Littlewood

Contact email: i.littlewood@panda-int.com
Job ref: 19027
Published: about 1 month ago

Senior QA specialist - Senior Specialist, EQ Small Molecule API

This position will provide the support to EQ Manager/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.
 

Your responsibilities:

  • Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of products at external manufacturers.
  • Conducts batch record review, investigations, performs audits, collects data, analyzes trends, and prepares reports as required.
  • Provides support to EQ Manager/Senior manager to ensures the success of external manufacturer qualification and monitoring, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability.
  • 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.
  • To support EQ account owner on the quality and reliability of products produced at the external manufacturer.
  • This role will support EQ account owner on the continuous oversight and management of:
  • Quality activities during manufacturing and quality control (including validations, issue management, trouble shooting, change management, supplier, and material management)
  • Execution of monitoring and auditing activities (including creation of quality agreements)
  • Assessing quality systems and recommending improvements to enhance quality
  • Reporting of quality activities, and as needed escalation of issues to senior management
  • To support EQ manager/senior manager in execution of quality activities such as New Product Introduction (through upscaling and launch), process improvements and significant changes.
  • Remaining current with local, regional and global Health Authority regulations, guidelines and quality practices associated with cGMP and API manufacturing.


Your profile:

  • Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Process technology / Chemical Engineering. Advanced degree (MS is preferred).
  • Ideally 6-10 years’ experience in Pharmaceutical or Biotechnology cGMP environment.
  • Experience in API, drugs or biologics quality management or manufacturing are 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.
  • 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, …).
  • Proficiency in computer applications such as the MS Office suite is preferred.
  • Knowledge of TrackWise is a plus.
  • Risk management abilities.
  • Demonstrated understanding of regulatory requirements that impact Quality Systems specifically, and external manufacturers.
  • Fluent in English.
 

Practicalities:

  • Location: Geel, Belgium
  • Hybrid work model: On-site 2 days a week
  • Some flexibility for occasional EU travel required (5-10%). 
  • Start date: ASAP
  • Contract: 1 year, with possibility of extension.
 

If interested, please send your CV to Isla Littlewood at i.littlewood@panda-int.com or contact +31 20 20 44 502 for more information.