MSD SrSpecialist External Quality 

Ireland 

372978326

Job Description

You will be accountable for ensuring that all of Company products managed by EQA (External Quality Alliance) are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements. You may also be accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution of the products manufactured at an EE and to assure they have been produced or tested following approved processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and Company policies.

Bring energy, knowledge, innovation to carry out the following:

• Assures compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc) both domestic and foreign.
• Evaluate and/or release products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures of the Company and compliance with all governing regulations; review and approve master batch records and changes to batch records and laboratory methods/specifications.
• Perform annual product reviews.
• Review executed batch records.
• Accountable for ensuring metrics are compiled, analyzed, and reported, including identification of trends and/or root cause(s) to help develop new initiatives and process improvements.
• Accountable for oversight of EEs involving releasing of products for further processing with the assurance that the goods were produced or tested in conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.
• Accountable for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied External Entity Oversight Level. These components may include review of batch documentation and deviation investigations.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).
• 5 years relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
• Must have strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships.
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership.
• Communicates in English, both verbally and in writing.
• Experience with biologic products and sterile drug product beneficial.
• Experience working with External Partners beneficial.
• Previous experience participating in regulatory inspections.
• Be conversant with all domestic and foreign regulations and compendia governing plant operations.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today.

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