MSD SrSpecialist External Quality 

South Korea, Seoul 

381863909

Job Description

Position Overview - Basic Functions & Responsibility

Essential function(s) includes, but is not limited to:

Individual contributor is accountable for ensuring that all of Company products managed by EQA are manufactured, packaged, tested, released, stored, and distributed in accordance with Company expectations and all applicable regulatory requirements. The incumbent 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.

Primary activities include, but are not limited to:

• 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.

Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice

REQUIRED: Education and Experience:

- Education: Minimum four year degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred).

- Minimum of 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.

Preferred Experience and Skills:

Experience with biologic products and sterile drug products

Experience working with External Partners

Previous experience participating in regulatory inspections.

Be conversant with all domestic and foreign regulations and compendia governing plant operations

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.