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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

Team Lead - QC Microbiology


Reference:AS24886 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Microbiology Lab Supervisor

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This position is responsible for ensuring that all microbiological and sterility testing associated with API testing is performed in accordance with all appropriate procedures and specifications. The role is not confined to laboratory operations but is involved in all aspects which may concern the microbial quality of the product, such as process validation, cleaning validation, method validation/transfer, environmental monitoring, critical site utilities & services, aseptic manufacture.

Duties:

  • Evaluates performance and provides opportunities for growth.
  • Communicates department objectives and metrics.
  • Implements changes in production methods, tooling and equipment, space allocations, workforce utilization, production schedules, lines and other factors required to maintain or improve compliance with quality standards of existing products and to establish initial and continuing compliance with Supervising the timely evaluation of complaints and returned product.
  • Initiates audits to verify that prompt and appropriate actions and associated corrections are taken.
  • Communicates metrics and systems used to measure and guide improvements to product and system quality and customer satisfaction to quality control staff.
  • Provides input to quality control reports, requirements and other information in response to requests for proposals, quotes and other business opportunities.
  • Provides input to budget planning process. Utilizes cost control initiatives to reduce expenses.
  • Implements methods and procedures for inspection, testing and evaluation.
  • Mentors, trains and supervises the quality control staff.
  • Supports QC Micro testing on day-to-day testing operations.
  • Performs Data and QC Investigations review and approval.
  • Reviews Specifications and plans for associated LIMS scheduling.
  • Reviews and approves Nonconformances, CAPA’s and Change Control records.
  • Plans and oversees lab related projects, i.e., Method transfer and optimisation, Equipment Qualification etc.
  • Provides superior technical support on specific microbiological technology.
  • Keeps abreast of microbiological technology and compliance trends.
Experience and Education:
  • Level 8 degree in a Microbiology/Science discipline.
  • A minimum of 5 years’ experience in a QC Micro role (at least 3 years in pharma) and at least 1 to 2 of those years in a TL or supervisory role
  • Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities applicable to pharmaceuticals and aseptic products.
  • Experience of managing project groups or leading teams.
  • Experience with Microbiological technologies and methods.
  • Expert in a wide variety of analytical techniques including but not limited to sterility testing, bioburden and endotoxin techniques, autoclave, environmental and utilities testing, and gamma irradiation.
  • Knowledgeable of FDA/EMEA regulatory requirements

If interested in this posting please feel free to contact Avishek Singh on +353 (0)87 282 7991 [email protected] further information.