QC Chemistry Supervisor

2 weeks ago

Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time

What You'll Be Doing:

The QC Supervisor will support the QC Chemistry team, overseeing the operation of a QC testing group by taking a hands-on approach to laboratory operations and supervising a team of analysts. Providing technical support for method validation, method transfer, regulatory updates, and new technology as required.

Your Responsibilities:

  • Lead a team of analysts in QC Chemistry by coordinating daily operations and ensuring team members are trained in their job functions and current revisions of relevant SOPs
  • Ensure high cGMP, GLP standards are maintained while testing, adhering to schedules and targets to meet regulatory and business requirements
  • Perform relevant assays on samples to support release test and stability test programs
  • Support validation and qualification of test methods and processes
  • Ensure audit readiness at all times
  • Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs, and validation
  • Prepare documentation for audits by internal auditors and Regulatory bodies
  • Facilitate laboratory investigations, troubleshoot methods and instrument problems
  • Represent the QC department in audits and close out actions/recommendations identified
  • Investigate out-of-specification/limit results and implement corrective actions

Your Qualifications:

  • B.A. / B.Sc. or equivalent in Chemistry or other biotechnical science
  • Minimum 8 years of laboratory experience in a GMP environment
  • Proven ability to work in a matrixed organization
  • Strong communication skills, including with higher level management
  • Good knowledge of current regulatory requirements for QC

Desired Qualifications:

  • Ability to develop collaborative relationships across functions and sites
  • Excellent problem solving and root cause analysis skills
  • Innovative approach in developing efficient and compliant processes
  • Strong organizational skills
  • Ability to plan, schedule, and delegate tasks effectively
  • Excellent written and oral communication skills

Date Posted:

23-Apr-2024

Closing Date:

27-May-2024Our goal is to create an inclusive and fair environment, where everyone feels they belong. We welcome applications from all qualified candidates and offer accommodations to support their best performance. If you require any adjustments, please indicate this in the application form.

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