Production Support Professional

Job description

Job overview:

This position is for Documentation support for manufacturing department.

Responsibilities:

·  Reviews manufacturing BPR (batch production records) to ensure compliance with internal specifications and cGMPs.
·  Scan and copy documents prior to submitting to QA. Manage cycle time for review and submission of documents.
·  Assures documentation is in compliance with cGMP regulations and ISO 13485 guidelines.
·  Update Batch Production Records as required.
·  Assist Manufacturing with BPR Printing and Issuance.
·  Drafts and reviews specifications and SOPs. Experience writing/reviewing SOPs
·  Close Work orders for completed batches using SAP system as per production plan.
·  May assist with formal CAPAs and NCRs as needed.
·  Monitors and trends batch record errors and provides manufacturing management with metrics.
·  Assist Departments with documentation Improvement Projects.
·  Perform data entry activities. Candidate should have a good working knowledge of all Microsoft Office tools and be Able to navigate various computer platforms (Live Link, StarLiMs, SAP and Track Wise).
·  Overtime as necessary.
·  Performs routine assignments with supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
·  Complying with requirements from Sanofi Genzyme's Safety Program including Health and Safety regulations and OSHA requirements.
·  Identifying and following up/leading opportunities to improve manufacturing processes and practices.

The ideal candidate must be detail-orientated, customer driven, outgoing, and a team player. Candidate should be organized and willing to learn from experienced personnel.

Basic Qualifications:

5+ years of experience working in a Pharmaceutical/Aseptic Manufacturing department for documentation support.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.