LSC have a great contract opportunity for a CSQA for MES to join a Cork based Biotech Drug Substance Manufacturing Facility.
This is an exciting opportunity to work with next-gen manufacturing technologies, advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.
If you have at least 5 years of relevant experience in a cGMP environment and ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide Quality leadership, direction, and governance for MES and MES related systems.
- Investigate and troubleshoot issues relating to MES and MES related systems.
- Manage Quality-related matters specific to area (Quality system or Quality Program) of responsibility.
- Approve appropriate quality-related documents. An approval signature confirms that site and GMP requirements have been met.
- Carry out day-to-day activities in compliance with site safety policies and procedures.? Promote and encourage safe practices and promptly report any safety concerns.
- Promote and encourage Quality culture and promptly report any compliance concerns.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- May hold BSc, MSc or PhD in Chemistry, Engineering, or related discipline
- Excellent attention to detail.
- Experience working in cross functional teams and proven ability in decision making.
- Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
- Strong organisational skills, including ability to follow assignments through to completion.
- Strong understanding of Data Integrity and its applications
- Self-motivated, positive and ability to work under pressure.
- Demonstrates flexibility and adaptability to meet business needs.
- Excellent interpersonal and communication skills (written and oral).
- Demonstrates a continuous improvement mind-set.
- Demonstrated initiative - able to work proactively without direct supervision, continuous improvement mind-set.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa.
Apply via this advert directly or call on 021 4777 329 if you have any more questions about this opportunity!
