Sr.Specialist External Quality

Job title: Sr.Specialist External Quality

Company: MSD


Job description: Job DescriptionA fantastic opportunity has arisen for a Sr.Specialist External Quality.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.Amount of Travel Required: Ability to travel up to 25%, occasionally on short notice.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.

As a company, 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.As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don’t hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.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 ourSo, if you are ready to:Invent solutions to meet unmet healthcare needs, please apply today.Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: RemoteShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 01/18/2025*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.

Expected salary:

Location: Dublin

Job date: Wed, 08 Jan 2025 07:29:15 GMT

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