Experience

Arch Pharmalabs, Ltd.

• India
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Senior Executive Production

  • Apr 2021 - Present

• Jr Executive

  • Apr 2017 - Present

   Supervised the process and executed the batches as per requirement.  Ensured that priorities met as per manufacturing plan all the time. APIs manufactured at my site, transferred to local & export market.  Actively participated in preparation for regulatory audits like US FDA audit and different Customer audits. Plant area was looked after during audits & VIP visits.  Priorities were given to satisfy the customers. Trained in cGMP, BMR, BPR, BRR, ECR, Balance Calibration, Documentation.  Expert in the Production module of SAP.  Excellent knowledge of SOPs, MSDS.  Familiar about COPQ (Cost of poor quality), ICHQ7A guidelines, Change Control, CAPA. Led a group of 10 to12 peoples. Ensured better utilization of manpower. Staff were communicated & trained time to time. Show less

• Officer Production

  • May 2015 - Apr 2017

  Supervised routine shop-floor activities by ensuring availability of material, BMR, BPR, intermediates required for daily production. Handled actual production process as well as unit operations like filtration, distillation, packing of finished material ,dispatching activity etc., as per standard operating procedures. Distribution and managing the required output from workmen.ISO Training to workmen in local language. Tracking of In-process, Final samples and timely entries in BMRs & BPRs.



M/S GlaxoSmithKline Pharmaceuticals Limited

• THANE SITE

• Manufacturing Executive

  • Jun 2004 - Sep 2013

  Supervised the process and executed the batches as per requirement. Ensured that priorities met as per manufacturing plan all the time. APIs manufactured at my site, transferred to local market & exported to European, Japanese and Korean market. Actively participated in preparation for regulatory audits like MHRA, KFDA ( Korean FDA ), PMDA ( Japanese FDA), MIA audit etc. Plant area was looked after during audits & VIP visits. Priorities were given to satisfy the customers. Trained in Lean Sigma, can assist in Validation of batches, Scaling of manufacturing, Troubleshooting in operations, 5S, cGMP, BMI, BMR, Balance Calibration, Documentation and EHS. Expert in Business Planning Controlled System (BPCS). Excellent knowledge of credible Mal-Ops studies, SOPs, MSDS. Familiar about COPQ (Cost of poor quality), ICHQ7A guidelines, VOC (volatile organic compound), Change Control, CAPA(Corrective and preventive actions). Completed Chemical Risk Assessment (CRA) of all APIs at my site. Implemented PCCE (Physical contamination causes & elimination) to improve quality of product. EMFT (Extraneous matter filtration test) of all batches monitored critically. Carried out self inspections for GMP & Safety. Led a group of 10 to12 peoples. Ensured better utilization of manpower. Staff were communicated & trained time to time. Well versed with cleaning & decontamination activity. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Skilled Staff

  • Jun 1993 - May 2004

  Manufactured bulk drugs. Hands on experience of working on the shop floor chemical plant- starting material 16-DPA was converted into end product Betamethsone and its derivatives involving functional group transformations.Carried out different chemical processes like Hydrogenation, Oxidation, Esterification, Precipitation, Bromination, Acetylation , Fermentation, and Dehydrobromination. Excellent knowledge of SOPs, and GMP. Manufactured bulk drugs. Hands on experience of working on the shop floor chemical plant- starting material 16-DPA was converted into end product Betamethsone and its derivatives involving functional group transformations.Carried out different chemical processes like Hydrogenation, Oxidation, Esterification, Precipitation, Bromination, Acetylation , Fermentation, and Dehydrobromination. Excellent knowledge of SOPs, and GMP.



Sanjeevani Pharmaceuticals Limited

• Rabale, Navi Mumbai

• Production chemist

  • Jun 1992 - Jun 1992

  Have manufactured Salines like D-5, D-10, DNS, RL and others, supervised from manufacturing to dispatch. Have manufactured Salines like D-5, D-10, DNS, RL and others, supervised from manufacturing to dispatch.