Officer

Job description

To ensure reporting of production QMS related if any for evaluation and closure.

Responsible for completion of Installation, Operational and Performance qualification of blending.

To ensure that the premises and equipment’s are maintained in validated state.

To ensure that the premises & equipment’s are maintained as per GMP requirements.

To monitor and ensure component preparation and sterilization activities.

To provide adequate training to all the staff related to process.

Responsible for ensuring & maintenance of aseptic area.

To plan man power according to production plan.

To ensure concurrent documentation as per GMP.

To ensure and carry out the operations related to APS.

To supervise and perform the blending of Shanchol, bivalent WcP mixing, DT and TT adsorption. To coordinate  with QA for issues related to SOPs, BMRs, change control and deviation etc.,

To ensure the availability of issued current controlled copies (SOP’s)  and submission of the superseded versions to QA.

Responsible for primary packing material indenting & follow-up with ware-house with respect to schedule.

To ensure the equipment preventive maintenance as per schedule.

To attend Safety PEP talk discussion with shop floor persons

To attend the committee meetings, contribute ideas and suggestions for improvements towards safety.

Report unsafe conditions and incidents to HOD & HSE

To maintain best practices and LEX reports, HSE trainings and safety alerts and audits

To provide orientation to new employees on health and safety risks and procedures in their work

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.