Management Associate- Production

Title: Management Associate Production

Purpose

Execute all Production activities for delivering required quality and quantity of products manufactured at Sanofi India limited by utilizing resources in optimum manner in order to ensure total customer satisfaction with adherence to GMP/HSE standards.

Key Areas

Adherence to Standard operating procedure and Batch manufacturing record and ensure ‘Right first time’ principle at work.

Granulation & Mixing area Activity and Documentation

To clean the Mixer Granulator/Co-mill/Stirrer/Fluid Bed Dryer, Tippler unit and other Accessories used in granulation process such as Hose pipes, solution vessels/scrapper/sieves/dutch sieves, finger bags/Screens for previous product/batch as per the instructions mentioned in Batch Manufacturing record of the assigned product.

To document details of cleaning the area, cubicle, and other equipment in the log book, cleaning record online/as soon as the activity is executed.

To check the cleaning due date before using the scoop, IBC, SSC, SC, Sieves and other manufacturing accessories before its usage, to check the cleaning status of manufacturing accessory: Sieves, Vibrosifter, polybags and others, equipment before its use for dispensing/addition activity for an assigned product.

To check and charge correct material and correct quantity, in the mixer granulator as per the GMID given in bill of materials in batch manufacturing record of the particular product.

To operate the purified water outlet in Granulation area and collect purified water for usage and document the details in BMR.

To prepare binder (as applicable) for the product by using the required binder provided by Dispensing team as per instructions mentioned in BMR. To operate stirrer as per RPM as mentioned in BMR.

To Operate the Mixer Granulator as per the standards mentioned in BMR/ instructions mentioned in the SOP. To document the critical process parameters and details such as: Amperage/Time required for binder addition/End point of Granulation process in the BMR. Ensure to Select correct recipe in Mixer granulator before starting the granulation process (if applicable).

To operate the Wet comill as per instructions mentioned in the Batch manufacturing record and respective standard operating procedure for the equipment. To document the details in BMR. Use correct screen size for milling of granules.

To operate the Fluid Bed dryer/Spray Granulator as per the instructions mentioned in the Batch manufacturing record and respective standard operating procedure for the equipment. Ensure to operate the fluid bed drier by considering the Product temperature, Inlet air temperature, Exhaust air temperature, Atomization Pressure are well within the specified limits in the BMR. Ensure to Select correct recipe in FBD before starting the drying process (if applicable).

To Sieve/Co-sift a material as stated in Batch manufacturing record as per the sieve number and document the details in batch manufacturing record. Ensure sieve integrity before and after its usage.

To operate the Tippler and Dry Comill, Other equipment’s such as: Ceramic heating vessel as per the instructions mentioned in the Batch manufacturing record and respective standard operating procedure for the equipment. Use correct screen size for milling of granules.

To carry out sieving (as applicable) for product in (Granulation IV) and carry out the process as mentioned in Batch Manufacturing record for applicable products.

To operate the pillar mixer, Cage blender and Octagonal Blender at Site. To check and charge correct quantity of lubricants in the Intermediate Bulk Container.

To check and dispense correct material and correct quantity of Valproic Acid (For applicable valproate range of products), as per the GMID and the control number mentioned in bill of materials in batch manufacturing record of the particular product.

To carry out and document daily performance verification, 6 monthly verification, repeatability, and eccentricity tests for Balances in granulation area as per the frequency mentioned in SOP, to carry out the verification of sieves/dutch type sieve as per the frequency mentioned in SOP and document the same.

Ensure that the products are manufactured and stored as per the requirements, storage instructions incorporated in BMR, ensure implementation of the quality system, Good documentation practice for BMR, logbooks and Log cards, ensure that all the data integrity ALCOA+++ attributes are followed and practiced at all times at workplace.

Following Discipline and decorum at workplace

Shift Handover and other communication

Line Compliance and Adherence to Quality standards

Training

Adherence to Site HSE Systems

Qualifications

Graduation, ITI or equivalent.

Any other requirements of the job

Must be able to deliver the task in timely manner.

Ensure the deliverables assigned as per the job description and as per the requirement of the organization.

Effective Communication skills with people and cross functional department.

Requirement

Person should have worked in production section of pharmaceutical industry

Experience in pharma industry is preferable

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.