Founder And Director

Nielesh  Shinde

Grade : Founder and Director – Ace pharma Consultation Services

Residence : Mumbai

Role : Microbiology Lead

 

Over 15 years of experience with Pharmaceutical Industry at various management positions at various locations and in different areas of Quality Control and Development

Highly experienced Auditor and faced several audits as an Auditee.

Well adjusted with the fast changing priorities in customer requirements by providing timely and effective support without loosing focus on quality.

Proven track record in implementing cost saving measures to achieve substantial reduction in terms of non value added activities without compromising on Quality.

Demonstrated excellence by improving standards of documentation and created quality team culture at various in house sites and contract sites.

Stream lined validation activities at various sites.

Effective communicator with excellent relationship management & decision making skills; possess a flexible & result oriented attitude with analytical skills.

Astute leader with ability to motivate subordinates in optimizing their performance levels and possesses excellent analytical, organizational & interpersonal skills.

 

Technical Director –

Microremediz Laboratories–Microremediz Laboratories is a dedicated facility for different types of microbiological testing required in Pharmaceutical Industry.

Providing end to end solutions to various microbiology testing needs of the pharmaceutical industry.

Conducting reviews of the client testing reports and their needs and providing them with scientifically correct solutions keeping in line with the Pharmacopoeia requirements and regulatory requirements.

Designing the study protocols for Sterility testing validation, Antimicrobial testing, preservative efficacy testing.

Conducting hands on training for college students.

Technical Director –

Micromaster Laboratories is a dedicated facility for production of various dehydrated culture media, ready to use culture media , stains and reagents and other microbiology consumable required for various microbiological activities required in all relevant industries.

Providing end to end solutions to various microbiology media needs of the pharmaceutical industry and other industries

Developing new media’s as per the requirements of clients for specialized purpose. Overseeing the entire quality requirements for their fulfillment as per the relevant standards

Providing technical assistance for designing cost effective solutions for the media requirements.

Providing effective media options for validation of aseptic process – Media Fill trails

Head Microbiology Development –

Cipla Limited – Handled GMP requirements various sister units of CIPLA, Well aware of the regulatory requirements in aseptic manufacturing.

Designed various microbiology lab layouts and did laboratory setup of around 10 microbiology labs. Well aware of the QMS required for smooth function of the sterile and non sterile facilities. Was Part of Micro Corporate core team and involved in OOS investigations, new product developments, method development.

Conducted Corporate GMP audits for manufacturing sites in Other Cipla Units across the India Part of internal audit team – Audited contract testing laboratories and contract manufacturing site.

Trending of Microbiology data that originate from manufacturing sites to help identify formula robustness versus plant manufacturing conditions.

Trained on Bacterial identification systems – API Vitek 2, BBL Crystal, MIDI – Fame Proficient all microbiological tests in Pharmaceutical Microbiology.

Senior Executive –

Johnson and Johnson – Spearheaded quality assurance of consumer product testing for timely release. Conducted quality assurance training for shop floor workers.

Technicial Expert –

Indian Council of Medical Research Served as sole technician in conducting polio virus identification by DOT-BLOT technique.

Developed expertise in handling tissue culture techniques and handling of cell lines.