Associate

Lupin Limited; Chhatrapati Sambhajinagar District; On-site; INR 300,000 - 600,000; Full time

Job summary

Lupin Limited in Maharashtra is seeking an Associate- Production to contribute to Granulation, Compression, Coating and Encapsulation activities within a tightly regulated pharmaceutical manufacturing environment.

The role requires adherence to cGMP standards, completion of SOP-based training, and meticulous documentation and reporting of any deviations or quality concerns to supervisors. You will participate in production, line clearance, and routine maintenance tasks alongside a dedicated team.

Qualifications

• cGMP and regulatory requirements must be followed.
• Complete training on relevant SOPs and understand activities before task.
• Report deviations and quality concerns to supervisors/managers.
• Maintain cleanliness and housekeeping per GMP.

Responsibilities

• Manufacture batches under supervision according to BMR.
• Handle raw materials and finished goods.
• Operate, wash and clean equipment per SOP.
• Support QA/QC with discrepancy reporting and corrective actions.
• Line clearance during batch/product changeovers as per SOP.
• Attend cGMP/On Job training and follow HR/planner directives.

Skills

cGMP familiarity

SOP comprehension

Quality mindset

Documentation accuracy

Job description

Job Description

Department: Production
Designation: Associate- Production
Working Section: Granulation, Compression, Coating and Encapsulation

Comply with all cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements.
Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
Conduct all tasks/activities as per the applicable SOPs. Report any difficulty or deviation in following the procedure/instruction to immediate supervisor/managers.
Report any quality concern or suggestion for improvement to supervisors/ managers.
Manufacturing / processing of batches of assigned products under supervision as per instructions given in the BMR.
Handling and movement of raw material, bulk, semi-finished and finished goods.
Operation, washing and cleaning of equipment’s and accessories used in related production activities as per respective SOP.
Up-keeping area and machines as per GMP requirements.
To Support Quality Management Systems and to report any discrepancy, abnormity, non-conformance or any incidence observed to the Department Head and QA Head.
Receipt of RM and PM from Warehouse and ensuring overall cleanliness of areas.
Doing operations as per the SOPs and BMR with online recording in respective documents as applicable.
To ensure self-hygiene before entering in the production area and follow all the other rules & regulation set by HR department.
Performing in-process checks as per respective BMR and recording of results of in respective documents as applicable.
To fulfil the training need as per current needs with respect to cGMP, Job, safety, health & Hygiene by attending the training programmes.
Cost effectiveness in production operation by controlling overtime, revenue expenses and achieving standard yield.
Critically monitoring of the environmental conditions with a view to meet the standards mentioned in BMR and SOP.
Ensure calibration and preventive maintenance of manufacturing equipment and instruments as per approved schedule and the results of same meeting the standards.
To perform line clearance activity during batch to batch and product to product change over and ensure the compliance as per SOP.
Issuance, retrieval and destruction of dies and punches, product dedicated bags and sieves, silicon sleeves, pipes, hose pipes and screens.
To ensure the audit compliance.
Trouble-shooting: To attend the problems of machine and process as and when necessary.
Any other assignment allocated by production Head.
To attend required cGMP/ On Job /Functional training activities as per planner.

Competencies

Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence