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Senior Associate QC

Reference ID : NHA36
Category :
  • Medical Devices
  • General Manufacturing
  • Pharma / Biotech
  • Science
Date Posted : Dec 19, 2017
Job Location
:
  • Leinster
- Dublin
Experience : 5+ Years
Salary : Neg
Employment Type
:
Contract
Consultant
:
Nicola O'Sullivan
Contact Number : 087 0622429
An experienced QC Specialist is required for a Dublin based 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:

• Bachelor’s degree in a Science related field is required. 
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, 
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

• Communication skills (verbal and written) at all levels 
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) 
b. Presentation skills 
c. Escalate issues professionally and on a timely basis 
• Decision Making skills 

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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