Senior Specialist Product Quality Manager (PQM) - External Quality Assurance (EQA) Sterile Job

Date: Jan 11, 2019

Location: Cork, IE

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Requisition ID: QUA008222



MSD Brinny



Are you ready to Invent, Impact, Inspire?



Join MSD and shape the future of healthcare in Ireland



INTRODUCTION 



At MSD Ireland, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.



THE COMPANY 



MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.

We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses. 

In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.

With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.



MSD BRINNY



MSD Brinny is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world. With a team of approximately 500 people, MSD Brinny specialises in the late-stage development and commercial supply of biotech products, including some of the company's most successful and life-changing treatments for oncology, hepatitis C and rheumatoid arthritis. 

The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers. MSD has invested €130m in the site since 2016 as a result of increased global demand for MSD medicines and vaccines which will see MSD Brinny further expand its production facilities and capacity to meet this demand. 



The Senior Specialist Product Quality Manager will be responsible for the following activities.

1. Perform EQA releasing of sterile products, manufactured at Contract Manufacturing Organisations (CMO) to downstream site with the assurance that the goods were manufactured in conformance with all applicable policies / procedures of MSD and in Compliance with all governing Regulations. 

2. Responsible for implementing Quality Control policy supporting the compliant supply of product by external manufacturers of sterile pharmaceuticals / biologics, by means of a risk based quality oversight, on site quality support and technical advice, counselling of manufacturing site senior leadership and providing routine on-site supervision as appropriate.

3. Provides Quality Control oversight for method validations/method transfers and method improvements at external parties.

4. The incumbent will review the executed batch records and ensure that the product has been produced in compliance with the approved batch record instructions and follow up and ensure timely close out of all corrections associated with the Batch Record Review.

5. Participate in routine weekly Tier 2 meetings / teleconferences between ExM Focus Factory and Contract Manufacturing Operations (CMOs). 

6. Co-ordinate the full investigation into all Customer Complaints received for any of the batches manufactured by the CMO s.

7. Assures CMO compliance with established policies / procedures of the Division and Corporate and complies with all applicable governmental Regulations (GMP, FDA, ANVISA,  etc.) 

8. Responsible for on-going execution of the Quality Agreement with the External Party.  

9. Contribute to EQA Management Operational and Strategic Initiatives.

10. Promote and participate in the implementation and maintenance of the SHE / EHS programmes relevant to you.

11. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up CAPA’s assigned to you.

12. Provide Quality Oversight to the preparation of the Annual Product Review Report for the products associated with the CMO.

13. Tracks and monitors Quality performance  / KPIs of the external manufacturer.

14. Assists in the co-ordination of significant investigations including Fact Findings. Assist in the co-ordination of any product recall involving the external manufacturer.


Qualifications



Degree or 3rd level qualification (Chemistry, Microbiology, Production, Mechanical, Process, Industrial, or Electrical or equivalent)  

Evidence of Continuous Professional Development..

Knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc) is desirable. 

Knowledge and experience in dealing with Quality related issues associated with third party Contract Manufacturing of Vaccine / Aseptic products (Vial, Syringes or Cartridges) is desirable.

Experience in the Pharmaceutical industry or a similar operating environment with experience in either a Quality, Technical or Operational role in a manufacturing environment.

Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, along with an understanding of regulatory and validation requirements.

Demonstrated leadership skills with a continuous improvement focus.



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.

 

Search Firm Representatives Please Read Carefully:  

MSD is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.




Job: Qual Assurce - 3rd Party Manuf
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Microbiology, Engineer, Biotech, Electrical, Medical, Science, Engineering, Healthcare

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