Assistant Manager (Manufacturing) – Contract Manufacturing - ALBERT DAVID LIMITED - Ghaziabad
(2015-06 - 2023-10)
- Supervision of Mfg./Packing activities as per GMP with necessary in process controls at LL site.
- Independently analyze daily report, monthly report and annual report.
- Involvement in process validation and cleaning validations, calibration activities etc.
- On site review and assistance in preparations of MFR's, BMR's, BPR's, PVR's, specifications, analytical and stability reports.
- Independently generate RM/PM requirement as per plan and involvement in timely arrangement of RM/PM at loan license site.
- Transportation arrangement for product delivery from contract manufacturing sites (LL & TP) and involvement in developing new transporters for betterment of freight charges.
- Coordination with concern dept. & involvement in commercial issues.
- Involvement in manufacturing of trial batches.
- Involvement with site management for complaint investigation and ensure CAPA are adequate and timely implementation.
- Coordinates vendor visits at LL site, if any issue found in RM/PM.
- Involved with site management for resources arrangement to achieve production targets.
Sr. Production Officer - B. BRAUN GROUP (PROJECT) - AHLCON PARENTERALS - Bhiwadi
(2014-08 - 2015-05)
- Man power planning and handling.
- Involvement with vendors in installation of equipments Like Mixing vessels, Holding vessels, PLC panels, Product & Utility piping, Clean room management.
- Visit the vendor site for FAT of equipments.
- Preparing the URS for equipment.
- Involvement in documentation review like DQ, IQ, OQ & PQ and SOP preparation.
- Work allocation to production team during equipment installation and area management.
- Involvement in arrangement of various equipments like trolleys, hydraulic lifter for clean room area for smooth work.
- Involvement with vendor for arrangement of garment cubicle, sterile garment cubicle, Cross over benches, SS tables and SS stands for various equipments like PLC panels, cubicles.
Production Officer (Approved Manufacturing Chemist) - POLYMEDICURE LIMITED - Ballabhgarh
(2010-09 - 2013-03)
- Handling Batch mfg., Packing & Final Packing areas.
- Scheduling the production plan for filling & packing area.
- Component planning with other dept.
- Man power planning and handling.
- Mainly responsible for documentation like Batch records completion, Sop's review and new Sop's preparation.
- Involved in Calibration, Validation activities, Ink Jet Printing project & different trials.
Junior Executive (Injectables) - IND SWIFT LIMITED - Baddi
(2010-06 - 2010-08)
- Supervision of Manufacturing and Packing activity.
- Scheduling the production plan separately for packing area.
- Man power planning and handling.
- Material management.
- Involved in different production activities like Batch records completion, Sop's review and involved in new Sop's preparation.
- Preparation of DPR, Weekly report, Monthly report related to production department.
- Monitor and involved in In-process checks during production activity.
- Maintain daily documentation (equipment log books & environmental monitoring records).
Manufacturing Chemist – Contract Manufacturing - BAXTER (INDIA) PVT. LTD. - Gurgaon
(2008-03 - 2010-05)
- On monthly basis, involved with site management in production plan scheduling to achieve production targets on time.
- Involvement with supply chain departments for dispatch plan schedule and ensure 100% schedule completion as per approved dispatch plan.
- Co-ordinate with transporters for timely dispatch of Goods from contract manufacturing locations as per approved dispatch plan.
- Reviewing all the documents like Testing reports (chemical and microbiological), BMR's / BPR's and validation protocol and ensure all quality documents are submitted to QA cell on time.
- Co-ordinates with different departments of contract manufacturing sites (like Production, Quality Assurance, Purchase and Ware house) for smooth functioning of Mfg. and packing activities as per GMP standards.
- Involvement with site management for complaint investigation and ensure CAPA are adequate and timely implementation.
- Resolve batch difficulties with site and involve in reject analysis in case of less yield in coordination with Contract Manufacturing department & Manufacturing Site QA.
- Independently prepare and share monthly report and annual report with concern department.
- Communicate and coordinate with QA Central Cell, Procurement and Supply Chain in case of any OOS of material.
- Follow up with sites for compliance of audit and visit observations.
- Conduct physical stock reconciliation of RM/PM at agreed frequency at contract manufacturing site and monitor their inventory.
Production Associate - BAXTER (INDIA) PVT. LTD. - Gurgaon
(2006-08 - 2008-02)
- Batch manufacturing responsibility with tank cleaning, CIP & SIP activities.
- Independently handle filling machine (Via flex Filler).
- Man power planning and handling.
- Material management.
- Involvement in internal audits.
- Batch records and SOP's review.
