Quality Control Technical Services Specialist

LSC, Life Science Consultants; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

LSC, Life Science Consultants, South Dublin, seeks a Quality Control Technical Services Specialist to oversee calibration, qualification and maintenance of laboratory equipment in a cGMP setting. The role emphasizes adherence to validation protocols and data integrity for biopharmaceutical testing.

The ideal candidate will have a Bachelor's degree in a science field and at least five years' lab experience, with hands-on lifecycle knowledge of analytical equipment qualification and regulatory

Qualifications

• Bachelor's degree in a Science related field is required.
• Minimum of 5 years of laboratory experience in a cGMP laboratory environment with exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of pharmacopeia analytical methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity 21 CFR part 11.
• Hands-on lifecycle and validation experience with analytical equipment in QC.

Responsibilities

• Plan, supervise calibration, requalification and maintenance of laboratory equipment per CMMS Maximo.
• Qualify new laboratory equipment in a cGMP environment and write validation protocols and summaries.
• Review and audit trails as part of validation lifecycle for computerized lab equipment.
• Schedule and coordinate equipment repairs with vendors to minimize downtime.
• Participate in technical project teams as SME on instrument validation regulations and procedures.
• Ensure calibration/maintenance activities are tracked in CMMS Maximo.

Skills

Laboratory experience

Analytical instrumentation

Data integrity

Regulatory awareness

Project collaboration

Education

Bachelor's degree in a Science field

Tools

Maximo CMMS

Validation protocols

Job description

LSC have a great contract opportunity for a Quality Control Technical Services Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

• Planning and supervising routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
• Conduct periodic reviews and audit trail reviews of as part of validation life cycle of computerised lab equipment.
• Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
• Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
• Responsible for ensuring that all service activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Bachelor's degree in a Science related field is required.
• Minimum of 5 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of pharmacopeia analytical methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity 21 CFR part 11.
• The successful candidates will be involved with routine activities and may be requested to support project work. For the most part project work consists of the introduction and qualification of analytical equipment for use in routine QC analysis and the candidate should have specific hands‑on laboratory equipment lifecycle and validation

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!