Senior Method Transfer Specialist Job - Ireland
MSD Carlow offers a fantastic Senior Method Transfer Specialist opportunity for candidates interested in a new challenge in a cGMP regulatory environment.
We are building a new state of the art Quality Operations laboratory, which will include Bioasssay and Analytical capability for our finished drug product testing for both vaccines and biologics. We are looking for Senior Method Transfer Specialists who will report directly to the Quality Operations Lab Lead to help us lead the start-up of this laboratory and achieve the milestones for analytical method transfers.
Provide technical expertise, trouble-shooting, training and support to laboratory analysts. Ensures Quality Control readiness to support all scheduled activities, consistent with Merck's requirements to ensure compliance, safety and reliable supply to our customers.
The ideal candidate will have 3-4 years experience in a performing method transfers. As a Senior Specialist, you will liase with analytical and technical subject matter experts from other Merck sites as well as participate in above site analytical and technical forums.
• Acts as a Laboratory subject matter expert for all analytical testing including but not limited to Bioassay, Immunoassay, HPLC,.
• Develop, implement and maintain procedures that comply with appropriate regulatory requirements for analytical method transfer and qualification.
• Leads method transfers and provides technical expertise, trouble-shooting, training and support to laboratory analysts.
• Ensures Quality Control readiness to support all scheduled activities, consistent with Merck's requirements to ensure compliance, safety and reliable supply to our customers.
• Required to comply with Merck Global Policies, Procedure and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Reporting to the Quality Operations Lab Lead the successful candidate will provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
• Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures
• Participate in the timely generation of investigations, non-conformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
• Manage and contribute to the achievements of department productivity and quality goals
• Represent the QC Department on site/inter departmental projects with Operations / Technical Engineering / Supply Chain as required.
• Represent the QC Department on on above site forums as required.
• Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Bachelor degree in in Chemistry / Analytical Chemistry, Biology, Biotechnology or related scientific discipline
• 5 years of experience in a pharmaceutical Laboratory.
• A strong background, with 3-4 years experience in performing / leading method transfers.
Initial Travel Requirements:
• The successful candidate will be expected to travel to other sites within Europe or the US for approximately 3 months training.
Job: Quality Operations Job Title:Sr. Spclst, Quality
Primary Location: EMEA-Ireland-Leinster-Carlow
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
External Job Board Posting: Ireland – IrishJobs – Advanced
Company Trade Name:MSD
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