PQR Specialist
PQR Specialist
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Job Description
At GSK we are committed to delivering products of the highest quality to ensure patient safety and regulatory compliance across global markets.
As aPQR Specialist you will play a vital role in preparing reviewing and managing Product Quality Reviews in alignment with industry standards and internal quality systems. Collaborating with cross-functional teams you will analyze data and ensure accurate documentation to support compliance and drive continuous improvement. This is an exciting opportunity to be part of a quality-focused team dedicated to maintaining excellence and fostering innovation in pharmaceutical operations.
Key Responsibilities:
Periodic Product Reviews (PQRs):
Manage and ensure the execution of PQRs for EU single schedules in alignment with approved procedures and timelines.
Oversee the preparation of PQR schedules based on product requirements and ensure adherence to the approved process.
Process Optimization:
Support the standardization and continuous improvement of the PQR process driving efficiency and consistency.
Collaborate on automation initiatives for LOC PQRs to streamline workflows and enhance productivity.
Subject Matter Expertise:
Act as a Subject Matter Expert (SME) for PQRs providing guidance and expertise to stakeholders.
Compliance Management:
Ensure compliance with all identified actions arising from Periodic Product Reviews.
Regularly update Standard Operating Procedures (SOPs) to align with relevant Global Quality Procedures (GQPs) and Global Quality Management Principles (GQMPs).
Performance Monitoring:
Share PQR status updates and recommendations during SQC (Site Quality Council) meetings ensuring transparency and alignment.
Continuous Improvement:Identify and share areas for improvement as a result of comprehensive product reviews fostering a culture of innovation and growth.
Why You
Basic Qualifications:
Bachelors degree in a relevant field (e.g. Pharmacy Life Sciences Quality Management).
Deep GMP regulatory background required to provide detailed knowledge to support decisions being made relating to MAH & PQR.
Understanding and knowledge of the systems and processes in relation to PQR process in the supply chain.
Proficiency in English for effective communication.
Why GSK
What we offer:
Career with purpose - whatever it is youre doing youll be sharing our mission to improve the quality of human life by enabling people to do more feel better and live longer.
Non-wage benefits (medical care life insurance pension scheme sports card recreation allowance social fund preventive healthcare services).
Hybrid working model ( 2 days per week in the office).
Career at one of the leading global healthcare companies.
Supportive & friendly working environment.
Corporate culture based onbeing Ambitious for patients Accountable for Impact and Doing the right thing which powers our purpose drives delivery of our strategy and helps make GSK a place where people can thrive.
We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team()to further discuss this today.
#LI-GSK #LI-Hybrid
Why GSK
Uniting science technology and talent to get ahead of disease together.
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 organisation where people can thrive. We prevent and treat disease with vaccines specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies investing in four core therapeutic areas (infectious diseases HIV respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders its 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 Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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