Associate Director, Quality Control (Microbiology)

Catalyst

Associate Director, Quality Control (Microbiology)


  Basel,
Posted
4 weeks ago
Duration
Permanent/Fixed Term
Salary
-
Sector
Internal

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My client is a global leader within the Life Sciences industry, operating across three continents. They are currently looking for an Associate Director of Quality Control for the Microbiology team, which is responsible for environmental monitoring (routine and production), utility monitoring, and microbiology testing such as endotoxin, bioburden, growth performance qualification and gram stain. The Associate Director will be responsible for oversight of the environmental monitoring (EM) program. This includes, establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and my client’s policy.

Key Responsibilities

  • Responsible for supervision of the Microbiology team. Acts as an advisor to subordinates when determining how to meet schedules and/or resolve technical problems. Reviews testing and laboratory records for accuracy and compliance with cGMP and my client’s policies and principles.
  • Leads environmental excursion investigations. Ensures corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
  • Writes, reviews, and/or approves SOPs, sampling plans, and protocols.
  • Prepares responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
  • Prepares project plans, writes status reports, and gives oral presentations to customers and management.

Key Requirements

  • 10 years’ experience within Quality Control
  • B.S degree required in science concentration preferred
  • Experience managing at least a team of 20 members
  • Working knowledge of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required.
  • Experience performing trending of environmental/utility monitoring data and conducting contamination/excursion investigations required.
  • In-depth understanding of concepts and principles in own discipline and a basic knowledge of these elements in other areas. Stays aware of new technologies and potential applications in area.
  • Develops training plans and performs identification and remediation of training gaps.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

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Contact

Email
+44 (0) 20 3589 9300
 

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