Senior Officer

Job description

Duties & Responsibilities :

· Provide line clearance for manufacturing operations in Shift A, B and C

· Perform "on the floor" quality oversight during manufacturing operations

· Review executed BMRs / Log books / Records and document the review comments appropriately

· Review and ensure sample collection as per defined sampling plan from each batch of product

· Responsible for monitoring, handling and control of retention/reserve samples.

· Identify and appropriately communicate the Shopfloor observations in a timely manner

· Prepare draft GMP documents (SOPs and  Data Record sheet)

· Work as a team member with a primary job of execution.

· Foster & follow HSE guidelines at all times. Ensure a safe working environment for self and others

. Should take up any additional tasks/assignments as per business requirement

Qualifications :

§  Post graduate / Graduate in Life sciences

§  Minimum of 2-5 years of relevant experience

§  Work experience in USFDA/EU regulated Sterile medicinal products is a plus

§ Vaccines / Biologics industry experience is a plus

Knowledge & Skills:

§  Good computer skills (MS Office - Word, Excel and PowerPoint)

§  Good communication skills

§ Knowledge of cGMP for sterile medicinal products manufactured by aseptic processing

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.