LSC have a great contract opportunity for a QC Technical Expert to join a leading biotech company based in in Ringaskiddy, Cork.
If you have 4 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:
- Qualification of analytical equipment and related testing functions, for example HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture and Total Organic Carbon etc.
- Co-ordinates & plans activities related to the successful transfer of Analytical Methods for relevant NMEs.
- Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product analytical testing and sampling.
- Support cGMP routine testing required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results.
- Perform data review assignments in accordance with the established laboratory procedures on data integrity and documentation.
- Drive, author, and review laboratory documents, such as protocols, reports, standard operating procedure, work instructions and other quality documents as per requirement.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- The candidate must have a strong technical knowledge of analytical techniques and strong knowledge of related laboratory equipment in one or more of the following areas: Chemistry, Biochemistry, Bioassay or Microbiology.
- Bachelor's Degree in Chemistry ,Biochemistry, Micro or science related field.
- 4-6 years related experience in biopharmaceutical or pharmaceutical industry and/or an equivalent combination of education and experience.
- Experience with Quality Control document reviews and regulatory inspection processes.
- Working knowledge of Quality systems.
- Strong technical knowledge in and experience with QC analytical testing methods and equipment is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
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!
Apply via this advert or contact Jenny Murphy at LSC on 021 4777329 if you have any more questions about this role!
