QA Release Senior Quality Reviewer

Swiftwater, PA

Full time

R2874116

** Job Title** : QA Release Senior Quality Reviewer

*
* Location:

** Swiftwater, PA

** About the job:*
* This role provides quality oversight of the Batch Release Protocol (BRP) process and final release to market. This role will perform final review and approval of all batch release protocols for both foreign and domestic submissions.

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and  Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

** Benefits of working in this role** :

+ Be part of an inspiring mission to create life-saving vaccines

+ Leading a skilled and motivated team of quality professionals

+ The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

** About Sanofi:*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

** Main Responsibilities*
* + Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

+ Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)

+ Reviewing and performing final approval of batch release protocols

+ Perform final approval of batch release protocol product configurations

+ Coordinate with supply chain and regulatory affairs to schedule batch release protocols and priorities

+ Perform ship approval for batches destined for international countries.

+ Fostering a culture of quality and continuous improvement across the organization

+ Participating in internal and external audits and regulatory inspections providing support and documentation

+ Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)

+ Collaborating with regulatory affairs to ensure compliance with local and international regulations

+ Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness

+ Participating in Quality Alert/Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots

+ Perform any other tasks assigned by Manager

** Key Involvement in Decision Making:*
* + Prioritize quality and compliance objectives (D)

+ Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

+ Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

+ Review and approve documentation for batch disposition (A)

+ Release of all stages of batches, focusing on the formulation, master/fill/inspect, and packaged stages

+ Advise on initiatives to promote a quality-focused culture (A)

+ Advise on how to present a topic and answer specific questions (A)

** About You*
* ** Basic Qualifications*
* + Bachelor's degree.

+ 3+ years of experience in Quality Assurance within the pharmaceutical industry.

+ Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance…