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QA Operations Manager (IPT)

Merck
Carlow
46 days ago: Merck

Job Description

Requisition ID: QUA008030

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.




MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.




MSD Carlow offers a fantastic opportunity for a candidate interested in a new challenge in a our expanding sterile form-fill site.
MSD Carlow are looking to recruit a QA Operations (IPT) Manager, who will be responsible for leading a team of specialists who are supporting the 24/7 Batch Manufacturing operation. Ultimately to ensure manufacturing and release activities are performed in compliance with applicable procedures, regulatory requirements and current Good manufacturing Practices (cGMP) .



They will be responsible for all people aspects, development, coaching and day to day management. Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. They will be required to develop and maintain training programmes. This Manager role will report directly to the Associate Director of Quality Operations.



The ideal candidate will have a minimum of 5 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a sterile manufacturing site in senior supervisory or managerial Quality and/or manufacturing role.



The successful candidate will have a proven ability to work collaboratively to drive a safe and compliant culture in Carlow.




Responsibilities:
Primary activities/responsibilities:



  • Provide compliance and technical leadership to the Operations and other support functions in resolution of investigations and assessment of proposed changes.

  • Facilitate the daily team meeting and ensure team representation at required cross functional forums.

  • Ensure the highest Compliance standards are met on a daily basis.

  • Ensure batch release times and all associated metrics are achieved.

  • Assist in the review of operational procedures, training materials and procedures for various systems.

  • Provide mentoring and guidance to the QA team, as well as Operations and other support functions to ensure manufacturing and release activities are performed in compliance with applicable procedures, regulatory requirements and current Good manufacturing Practices (cGMP)

  • Work Closely with the Quality Leadership Team (QLT) on key operational and strategic areas

  • Delivery of area performance to meet or exceed performance and quality goals

  • Drive performance and management of individuals and team

  • Participate in corporate and regulatory audits as required
Qualifications

Minimum Education:



  • Third level qualification (Degree) in a science related discipline.

  • Preference for Lean Six Sigma Green Belt

Minimum Experience:



  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices

  • Knowledge of cGMP and Quality Systems as they relates to sterile filling operations

  • 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a front-line supervisory role in operations environment.

  • Demonstrated leadership and change management skills with a continuous improvement focus

Initial Travel Requirements:



  • Very occasional travel may be required.


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD
Requisition ID: QUA008030 MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.     MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our...