LSC has an exciting opportunity for a C&Q Tech Writer to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Defining approaches and standards to enable C&Q activities to be carried out consistently and efficiently and in conformance with applicable regulatory expectations ( quality, safety and/or environmental) and established industry standards (e.g. ISPE Guidelines etc.)
- Generating / Updating procedures including templates.
- Prepare demolition, mechanical completion, IV, OV documents in accordance with templates.
- Prepare Risk Assessments, Commissioning & Qualification Plans, Verification Plans, Summary Reports and UR Documentation in accordance with templates.
- Ensure all personnel and those executing protocols are adequately trained in C&Q procedures.
- Ensure all commissioning & qualification documentation complies with all relevant local and global corporate procedures.
- Ensure that all commissioning & qualification documentation is executed in the correct order.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Ability to multi-task, prioritise and manage time efficiently.
- Knowledge of Regulus system is desirable.
- Track record in delivery of GMP facilities / C&Q projects.
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!
Call Sarah Ninan at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert