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Senior QC Analyst

Ref: 75202

  • 40,000-45,000
  • 12 Aug 2021
  • Tipperary
  • Permanent

Senior QC Analyst

About the Company

This is a great opportunity for an experienced QC Analyst to take on a Senior role at a growing site as they move towards full commercial production.

About the Position

This is an initial 12 month contract role working on a day shift. Previous experience working on Inhalation products is highly desired.

Key Responsibilities 

  • Technical Laboratory SME with experience representing company in regulatory audits (i.e. front room experience responding to FDA / HPRA audit queries)
  • Detailed understanding of Inhalation product testing requirements.
  • Ability to translate knowledge on Inhalation product testing to the laboratory testing program.
  • Supports Laboratory Set-up activities
  • Prepares Laboratory procedures, specifications, protocols & reports as required
  • Performs Laboratory testing and investigations per SOP, applicable regulations and cGMP
  • Performs peer review of documentation as required
  • Performs Analytical method verification, validation and technical transfer as required
  • Supports Laboratory/Site EHS governance
  • Performs management of Laboratory consumables ordering and tracking
  • Assists in Equipment Qualification activities, ordering and tracking as required
  • Supports preparation for regulatory audits/visits and ongoing audit readiness
  • Supports development of QC Testing processes
  • Liaises with CROs and audits where appropriate
  • Report problems with quality, processes and materials to the HOD.

Experience/Requirements 

  • Degree in Analytical Chemistry or similar
  • 3-5 years of experience in a cGMP QC testing lab
  • Inhalation experience is highly desired

 

Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.