Senior Specialist QA External Manager
il y a 1 semaine
Site Name:
Belgium-Wavre, GSK Tres Cantos, Madrid
Posted Date:
Mar
_ QA Manager External Manufacturing - CMO _:
- Job purpose: _
- Take responsibility for the Contract Manufacturer Quality oversight quality aspects (QA and QC) within the group of Tech Transfer / External Manufacturing Operations.
- Ensure the release of the commercial batches in compliance with the Good Manufacturing Practices and regulatory requirements
- Maintain the compliance level with GMP regulations/requirements and GSK Biologicals standards within the External Supply
- Provide support to Global Regulatory Affairs (GRA) for activities linked to the External supply operation and ensure that the commercial batches are always manufactured in accordance with regulatory files.
In this role you will
- Be the quality contact point for the selected contractors / suppliers you are responsible for (in transfer or in commercial operations)
- Ensure that Quality systems are in place/in use, routinely monitored and assessed
- Release all validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
- Ensure accountability for all quality activities linked to the contractor / supplier management (deviations, CAPA closure, risks management, complaints, product quality review,)
- Ensure and maintain good relationships with the contractor in order to guarantee winwin collaboration, through informal meetings and governance meetings. Max 25% travel to be expected over the year.
- Represent the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
- Maintain knowledge and experience up to date in the light of technical and scientific progress and changes in quality management
- Manage change Control at External Manufacturing site. Perform initial assessments of the potential SQIPP and RA Files impact of changes proposed by the site
- Be part of the Regulatory Submission Building Process at External Supply level and site conformance if required.
- Contribute to documentations preparation,
- Provide accurate source data in support of regulatory submission creation,
- Provide documents for inclusion in dossiers, ensure CMC dossiers sections are reviewed to confirm alignment with shop floor practices
- Provide support, approve dossier sections relevant to the site.
- Escalate to N+1 if necessary
- Manage Questions & Answers packages and commitments linked to Health authorities' requests in due time
- Take transversal responsibilities for quality systems within the scope of Virtual site team, act as Subject Matter Expert
- Accountable to identify risk associated to the specific activities of the CMO
_ Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade._
_ Why you? _
- Qualifications & Skills_:
- University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer).
- 5 to 10 years of experience in Pharmaceutical Industry associate with a strong GMP background
- Experience as a QA or production manager, with expertise on the field, in quality systems or release
- Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
- Fluent in written and oral English is mandatory
- Travel expected (1015%)
- Preferred Qualifications & Skills:_
- Good interpersonal, communication (including presentation) and influencing skills
- Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks
- Ability to create and maintain networks
- Creative approach to problem solving
_ Why GSK?_
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people.While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Toget-
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