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Sr. Specialist, External Quality

1 mese fa

Rome, Italia MSD France A tempo pieno

An amazing opportunity has arisen for an External Quality Senior Specialist. You will be accountable for ensuring that all products 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.

Ability to travel up to 25%, occasionally on short notice.

This role will be to support EU-based External Partner, as such remote working considered.

Responsibilities include, but are note limited to:
 

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

  • Being responsible for implementing Quality Control policy, supporting the compliant supply of product by external manufacturers of sterile pharmaceuticals / biologics / vaccines, by means of a risk based quality oversight, support and technical advice, counselling of manufacturing site senior leadership and providing on-site supervision as appropriate;
  • Reviewing the executed batch records and ensure that the product has been produced in compliance with the approved batch record instructions;
  • Evaluating and/or releasing products with the assurance that the goods were manufactured in conformance to all applicable policies/procedures and compliance with all governing regulations; reviewing and approving changes to master batch records or laboratory methods/specifications;
  • Taking responsibility for oversight of an External Entity (EE), 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 and compliance with all governing regulations;
  • Providing Quality Control oversight for method validations/method transfers and method improvements at external parties;
  • Following up and ensuring timely close out of all corrections associated with the Batch Record Review;
  • Participating in routine weekly Tier 2 meetings / teleconferences between ExM and Contract Manufacturing Operations (CMOs);
  • Co-ordinating the full investigation into all Customer Complaints received for any of the batches manufactured by the CMOs;
  • Assuring CMO compliance with established policies / procedures of the Division and Corporate and compling with all applicable governmental Regulations (GMP, FDA, etc.);
  • Being responsible for on-going execution of the Quality Agreement with the External Party;
  • Contributing to EQA Management Operational and Strategic Initiatives;
  • Operating in a safe and efficient manner and in compliance with the Safety and Health Policy;
  • Promote and participate in the implementation and maintenance of the SHE / EHS programmes relevant to you
  • Participating in risk assessments, inspections, audits, incident investigations, etc., and implementing and following-up CAPA’s assigned to them;
  • Providing Quality Oversight to the preparation of the Annual Product Review Report for the products associated with the CMO;
  • Being 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;
  • Assisting in the co-ordination of significant investigations, including Fact Findings. Assisting in the co-ordination of any product recall involving the external manufacturer.

Qualifications

Education and Minimum Requirements:
 

  • Degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred);
  • Minimum of 3 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.

Required Experience and Skills:
 

  • Must have strong stakeholder management, communication, coaching,
    motivation, negotiation, and persuasion skills to build strong relationships;
  • Ability to work across boundaries;
  • Demonstrated interpersonal, relationship building, and leadership skills;
  • Good English level, both verbally and in writing;
  • Eligibility as Qualified Person it's preferred.

Current Employees apply

Search 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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

08/17/2024

*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.


Job Posting End Date:08/17/2024


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.


Requisition ID:R302017