QC Analyst
Our client, a pharmaceutical company in Co. Carlow, is seeking a QC Analyst for an initial 11‑month contract. This is an onsite position and it is a shift role not including nights. This is an entry‑level QC position, suiting recent graduates with 1‑2 years of experience.
You will perform and review a range of techniques such as immunoassays, cell‑based potency bioassays, HPLC and compendial methods as part of routine and non‑routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release.
Responsibilities
* Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day‑to‑day activities and all applicable job functions.
* Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day‑to‑day activities and all applicable job functions.
* Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
* Ensure that all Quality Systems within the department are adhered to on a daily basis.
* Operate as part of the QC team performing the allocated testing and laboratory‑based duties.
* Ensure timely completion of all assigned data processing and reviewing.
* Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.
* Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
* Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
* Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
Requirements
* Bachelor's Degree or higher preferred; ideally in a science‑related discipline.
* A great communicator, decisive decision‑maker with a proven ability to deliver excellence.
* Ability to participate in highly‑effective teams.
* The desire to continuously learn, improve and develop.
* Strong leadership and interpersonal skills.
* Willingness to support the team and a strong focus on delivering excellence.
* High personal integrity, credibility, energy and flexibility.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at 086 1263871 or send your CV to doconnell@berkley-group.com.
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