Rajesh Gour Email & Phone Number | • Hands on experience of leading different functional areas of pharmaceutical quality system i.e. quality assurance, quality control (chemical & microbiology), IPQA, CQA, audit &compliance. • Headed for overall management and compliance of centralized microbiology lab; Lead 55+ Staff • Led Quality Assurance of Sterile Manufacturing for its overall compliance • Microbiology subject matter experts; expertise in maintenance of cGMP; developing, updating and reviewing Quality Systems; Root Cause Investigations, Implementation of CAPA activities; OOS/Deviation Management; Compliant Handling, Aseptic Process Simulation and Process Optimization. • Well-versed with operating of quality management software documentation i.e. Trackwise, Document Control Management, Learning Management System. • Exposure of process, cleaning, disinfectant &method validation, batch review and release. • As functional head, led multiple successful regulatory inspections like USFDA, MHRA, TGA, EDQM, ANVISA, MCC-SA, Health-Canada, MOH, Ukraine, WHO, and many others for injectable, sterile and nonsterile API and oral formulations. • Experience of leading corporate vendor qualification, vendor Audits and contract manufacturing teams in regulated environment. • Certified quality investigator and auditor. • Believe in team work, people development, Resource management, Control of attrition rate. • Capex and revenue budget management; ensured No access & shortage of materials. • Independently handled new lab project/setup for overall design and qualification of area, HVAC, water system, equipment/instrument; biggest ART of STATE Microbiology Lab in Asia.

Rajesh Gour

• Hands on experience of leading different functional areas of pharmaceutical quality system i.e. qu...
Indore, Madhya Pradesh, India

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Rajesh Gour’s Email rajeshgour21@rediffmail.com

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Rajesh Gour’s Location Indore, Madhya Pradesh, India

Rajesh Gour’s Current Industry Ipca Laboratories

Rajesh Gour’s Prior Industry Emcure Pharmaceuticals | Sun Pharma | Orchid Healthcare | Zydus Cadila Healthcare | Aristo Pharmaceuticals

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Work Experience

Ipca Laboratories

Head Microbiology At Ipca Ratlam

2021-11-01 00:00:00 - Present

Emcure Pharmaceuticals

Deputy General Manager - Quality & Compliance

2018-11-01 00:00:00 - 2021-06-01 00:00:00

Sun Pharma

Senior Manager Quality Control / Quality Assurance

2007-04-01 00:00:00 - 2018-11-01 00:00:00

Orchid Healthcare

Assistant Manager - Head Qc Microbiology

2006-03-01 00:00:00 - 2007-04-01 00:00:00

Zydus Cadila Healthcare

Senior Executive - Head Qc Microbiology

2003-08-01 00:00:00 - 2006-02-01 00:00:00

Aristo Pharmaceuticals

Senior Officer - Qc Microbiology

2000-04-01 00:00:00 - 2003-07-01 00:00:00

Skills

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Languages

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FAQ About Rajesh Gour

Rajesh Gour is located at
Indore, Madhya Pradesh, India

Rajesh Gour is a • Hands on experience of leading different functional areas of pharmaceutical quality system i.e. quality assurance, quality control (chemical & microbiology), IPQA, CQA, audit &compliance. • Headed for overall management and compliance of centralized microbiology lab; Lead 55+ Staff • Led Quality Assurance of Sterile Manufacturing for its overall compliance • Microbiology subject matter experts; expertise in maintenance of cGMP; developing, updating and reviewing Quality Systems; Root Cause Investigations, Implementation of CAPA activities; OOS/Deviation Management; Compliant Handling, Aseptic Process Simulation and Process Optimization. • Well-versed with operating of quality management software documentation i.e. Trackwise, Document Control Management, Learning Management System. • Exposure of process, cleaning, disinfectant &method validation, batch review and release. • As functional head, led multiple successful regulatory inspections like USFDA, MHRA, TGA, EDQM, ANVISA, MCC-SA, Health-Canada, MOH, Ukraine, WHO, and many others for injectable, sterile and nonsterile API and oral formulations. • Experience of leading corporate vendor qualification, vendor Audits and contract manufacturing teams in regulated environment. • Certified quality investigator and auditor. • Believe in team work, people development, Resource management, Control of attrition rate. • Capex and revenue budget management; ensured No access & shortage of materials. • Independently handled new lab project/setup for overall design and qualification of area, HVAC, water system, equipment/instrument; biggest ART of STATE Microbiology Lab in Asia.

Rajesh Gour currently works in the Ipca Laboratories |

No Languages Available

Rajesh Gour has prior
experience in the following industries:
Emcure Pharmaceuticals | Sun Pharma | Orchid Healthcare | Zydus Cadila Healthcare | Aristo Pharmaceuticals

Rajesh Gour has the following professional experience:
Ipca Laboratories | Emcure Pharmaceuticals | Sun Pharma | Orchid Healthcare | Zydus Cadila Healthcare | Aristo Pharmaceuticals