External QA – Snr Specialist EU Region
MSD Switzerland
Belgium
7 dagen geleden

Description

Are you ready to Invent, Impact, Inspire?

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

  • Responsible for ensuring that all MSD products managed by EQA are manufactured, packaged, analyzed, released stored and distributed in accordance with MSD expectations and all applicable regulatory requirements.
  • Ensures the Quality performance of external parties / partners through direct oversight, support and counselling to the partner.

  • These activities include involvement in most aspects of external manufacturing operations related to the quality of products produced.
  • The incumbent is responsible for the release of all manufactured products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies.
  • The incumbent exercises a leadership role in monitoring and maintaining the ExM compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements
  • POSITION RESPONSIBILITIES

  • Assures compliance with established policies / procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.
  • both domestic and foreign

  • Operates in a safe and efficient manner and in compliance with our Manufacturing Division QO Safety and Health Policy.
  • Supports ESQL with the development and maintenance of a Quality Agreement with the external parties / partners. May provide input into the development of contractual agreements with the external manufacturers.
  • Reviews all audit outcomes pertaining to external manufacturers and ensures appropriate and timely corrective actions were warranted.
  • Responsible for coordination, oversight, and communication on matters related to the GMP status of the external manufacturer.
  • Must be conversant with applicable regulations and compendia (domestic and foreign) governing the external party / partner’s operations.

  • Closely collaborates with appropriate business / operations and technical areas to achieve MSD objectives.
  • Acts as the MSD Product Quality point of contact for the external party / partner and the liaison for contact and communciations between the external party / partner and internal MSD personnel sipporting the ESQL role.
  • Exercises a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the external party / partner.
  • Tracks and monitors operational and quality performance of the external party / partner. Monitors efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communicationprograms and forums.

  • Works with the external party / partner to ensure that effective and robust Quality systems and Quality management are in place.
  • Provides on-site guidance in the preparation of metrics, procedures, and guidelines where warranted. Provides proactive support in training and coaching to initate quality improvements.

  • Provides guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
  • Responsible for evaluation and / or release of products to other sites and / or to the market with the assurance that the goods were produced in conformance to all applicable policies / procedures of MSD and compliance with all governing regulations.
  • Leads the responding to complaints from domestic and international markets.
  • Ensures that all deviations at external manufacturer / partners related to MSD Products are fully investigated with any assigned actions effectively implemented within the agreed time frame.
  • Provides proactive support in training and coaching to initiate quality improvements within Operations and Quality; reviews Annual Product Stability and Annual Product Reviews
  • Creating and managing routine and / or compendial change control
  • REPORTING STRUCTURE

    Associate Director External QA

    Qualifications

    QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

    General

  • BS degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent.
  • Minimum of 5 years’ experience in pharmaceutical industry witha thorough knowledge of quality systems, regulatory requirements and GMP.
  • Must have strong knowledge of and broad experience in product Quality Assurance and Quality Control activities.
  • Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
  • Communicates easily in English both verbally and in writing.
  • Must have very strong relationship building skills.
  • Some level of contractual and financial awareness is required.
  • Qualified Person according to Article 48 of Directive 2001 / 83 / EC (preferred not required)
  • So, if you are ready to :

    INVENT solutions to meet unmet healthcare needs

    IMPACT the future by joining MSD, one of the world’s leading healthcare companies

    INSPIRE your team to reach their full potential and push the boundaries of science and technology

    Search Firm Representatives Please Read Carefully :

    MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.

    All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

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