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Senior Associate QC

Reference ID : NHA91
Category :
  • Medical Devices
  • General Manufacturing
  • Science
  • Pharma / Biotech
Date Posted : Dec 19, 2017
Job Location
:
  • Leinster
- Dublin
Experience : 4-5 Years
Salary : Neg
Employment Type
:
Contract
Consultant
:
Nicola O'Sullivan
Contact Number : 087 0622429
QC Specialist required to join the Bioanalytical Sciences team within a leading pharmaceutical multinational

Principal Responsibilities

Senior Associate QC

Currently seeking to recruit a Senior QC Specialist to be based on our client site, a leading Dublin based pharmaceutical multinational.  The successful candidate will be responsible for leading, coordinating, facilitating and undertaking activities pertaining to lab operations and compliance.

Key Responsibilities:

  • Experience in a wide variety of analytical techniques including but not limited to Bioassays, Immunoassays, Cell Culture and Aseptic Techniques
  • Plan and perform multiple complex routine/non-routine methods and procedures and a large variety of assays
  • Participate in the peer review of analytical data
  • Responsible for providing technical guidance and applying expertise and critical thinking to help resolve technical issues
  • Qualification of analytical equipment and related testing functions
  • Participate in Analytical method transfers
  • Maintain quality systems within the QC labs to ensure ongoing compliance
  • Ensure timely completion of Lab investigation reports and deviations through non-conformance procedures
  • Participate in the generation and update of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
  • Participate in regulatory agency inspections as required

Qualifications & Requirements

Qualifications and Experience:

  • BS in Biology, Biotechnology or related discipline
  • 4-5 years in a similar role within the bio/pharma industry
  • Strong background in Bioassays, Immunoassays and Cell Culture
  • Knowledge of applicable regulatory requirements
  • Experience with Regulatory inspections and interaction with inspectors is preferable
  • Experience with Trackwise, change control systems, EDMQ and SAP is an advantage
  • Excellent communication and management skills
  • Ability to work with cross functional teams at varying levels of seniority

For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie



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