Cpl in partnership with our client Pfizer are currently recruiting for a LIMS Specialist based in their Grange castle Site.
This is an exciting opportunity to join the Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant which is situated on a 90-acre site in South Dublin. Grange Castle's state of the art technology & production expertise results in the production of quality-driven products that improve people's lives around the world.
To collect relevant documentation, to draft, test, verify, transfer, review, and activate LIMS master data records in the LIMS system. This includes all records necessary to build the environment for the applicable functional area to record and report data associated with QC Testing. To assist in validation (IQ, OQ, PQ) as required.
- Develop expert skills in the building, testing, verifying, transferring, reviewing and activation of all data required for Master Data Load in LIMS.
- Develop expert skills in reporting.
- Identify functional area end user requirements and enhancements following drafting and Review of the Master Data Load in LIMS.
- Be responsible for data loading for validation and ongoing operations for the applicable functional area.
- Assist in additional duties as directed by Manager.
- Maintain required forms for the LIMS system.
- Adhere to relevant documents; including SOPs, specifications and forms to ensure Master Data Load is completed using current documentation.
- Assist in the collection of the relevant documentation to support the Master Data Load.
- Ensure knowledge of job function is current and in-line with effective training material.
- Adhere to appropriate levels of cGMP when performing Master Data Load.
- Adhere to local safety regulations.
- Facilitate review of all Master Data Load in LIMS by relevant functional area.
- Ensure the system master data is updated in a timely manner as required by the functional area.
- Work in conjunction with both LIMS team members and users to ensure compliance, across all user groups.
- Contribute proactively within the LIMS team for the development of the business and fully collaborate with all other members of the team and all staff members
- Perform any other duties that are assigned to you by your Manager and for which you have been provided with reasonable knowledge and training in respect of such responsibilities
- Degree biological/chemical sciences or other related technical degree/diploma.
- Experience in QC environment and or a pharmaceutical GMP/GLP or GCP facility is desirable.
- Previous experience with LIMS Master Data or similar system is preferred.
- Knowledge of GMP and validation processes.
- Must be able to work independently, but also as part of a team.
- Proven ability to Problem Solve/Troubleshoot.
- Strong organization skills, including ability to follow assignments through to completion.
- Ability to work independently and as part of a small team.
- Proven high level of attention to detail.
- Proactive, self-starter.
- Demonstrate the GC OWNIT values
- Adhere to all HR Policies as appropriate
- Personal Development plans focus on the 70:20:10 guidelines
- CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
- Proactive engagement with key stakeholders.
- Best practices developed and shared with other teams /sites.
- Best practices actively sought and copied.
- Proactive & effective communication within and across shifts
- Maintain an openness to feedback on one’s own performance and a commitment to implementing agreed performance/behavioural changes
- Behave at all times in one’s dealing with colleagues and customers to
the highest ethical standards particularly ensuring that one treats all those with whom one comes into contact with full dignity and respect