IPT Specialist Operations - Manufacturing Support Job - Ireland
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The IPT Specialist Operations will be based on the company , site and will sit within the IPT (Operations) organisation, reporting to the Process Support Coach for IPT.
- Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
- Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
- Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP’s, SWI’s, training documents, and change controls.
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
- Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
- Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
- Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
- Required to comply with Merck 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.
Typical Minimum Education:
Degree qualification in a Science/Engineering related discipline essential
Typical Minimum Experience:
- 5+ years experience in the Pharmaceutical or Manufacturing industry.
- Strong interpersonal and communication skills and strong understanding of Pharmaceutical GMP systems are essential.
- 3+ years experience of writing complex deviations essential.
- Knowledge of Aseptic Manufacturing and experience in Management is considered an advantage
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.