Ritika V.

Microbiologist having over 18 years of insightful experience in reputed organization as head Microbiology Quality Control section. Unique skill to manage team work. Trouble shooting & finding solution for non-conformance cases.

Very good hand on preparation and execution of protocols and reports for the all the validation and qualification activities in QC microbiology. Hand on the investigation of OOS, OOT, OOC, Deviations, and Laboratory incidents. Exposure and knowledge of QMS activities like handling and review of change controls, deviations and CAPA.

Monitor

Plant hygiene/ Microbiological robustness from Quality perspective.

Supervision QC microbiology department at Sun Pharmaceuticals industries ltd Karkhadi (Varodra) Ltd. (2014-07-25 – Present)

This unit is EOU and Manufacture API. Looking after Microbiology lab. Ensuring all the activities in microbiology section are in compliance manner with respect to c GMP regulation.

• Establish partnership with operations & Implementing Quality Related programs based on the cGMP, Cleaning & Sanitization guideline, Manufacturing Micro & Regulatory Guideline - that ensure all production meets the requirements of the current Quality Standard.
• Handling various QA systems like Quality Event Reporting & Consumer / Customer Complaints, SOPs, Change control Management & Process Validations etc. Member of Quality Pillar (part of Integrated work system) implementing of various quality tools and developing robust action plans for Quality Incidents & Quality related loses via unified problem solving for incidents.
• Ensure that all Analysis of RM/In process and FG is done as per recommended Analytical Methods as well as Microbiology test standards.
• Responsible for overall functioning of the Microbiology lab in accordance with cGMP and Regulatory requirements
• Maintain inventory and records for media, culture, chemicals, spares, glassware. Handling vendors related to the Micro lab
• Validation /qualification & documentation of equipment and methods related to Micro lab. Validation/ monitoring systems eg: Environment monitoring, Purified Water system validation and their trending/record maintenance.
• To checked microbial limit test. Media preparation, Growth Promotion test.
• Monitor Plant hygiene/ Microbiological robustness from Quality perspective.
• Maintenance & procurement of culture standard & laboratory regents.
• Planning and checked calibration, Validation and preventive maintenance of critical equipment like Autoclave, Hot air Oven, BOD, Bacteriological Incubator, colony counter, Laminar Air Flow, water bath, Refrigerator, etc. & Related documentations
• Culture & Bioball Checked audit trial for TOC Instrument and calibration.

Executive Microbiology department at J.B.chemicals & pharmacuticalsltd.ankleshwer (2010-12 – 2014-07-21)

• Routine microbial analysis of Water, Raw materials, and finished product. Environment monitoring activity preformed in Microbiology Lab and production area
• Media preparation, Pre-incubation, and Growth Promotion test performed
• Toxicity test performed for Small and large volumes Injection. Operation of autoclave.

Q.C officer at Aarti drugs ltd sarigam vapi (2007-03 – 2010-11)

Aarti drug is Manufacturer of Bulk Drugs (API).

• Perform MLT of purified water, & Finish product
• Environmental monitoring of production area, Preparation of SOP and daily calibration of instruments.
• Routine microbial analysis of Water, Raw materials, and finished product. Environment monitoring activity preformed in Microbiology Lab and production area

Q.C Chemist at AGOG PHARMA LTD VASAI (E) (2005-05 – 2007-02)

They are manufacturer of Tablets, Capsules & Syrup. They are Sole Supplier of leading companies Ajanta pharma, Elder pharma & Indoco remedies.

• Perform MLT of purified water, & Finish product
• Environmental monitoring of production area, Preparation of SOP and daily calibration of instruments.
• Routine microbial analysis of Water, Raw materials, and finished product. Environment monitoring activity preformed in Microbiology Lab and production area

PGD in Clinical Research – ICRI Mumbai (2007 – 2008)

MSc. in biotechnology – Jawalal P.G College Bhopal (2005 – 2005)

BSc in Biotechnology – Marwari College Ranchi (2002 – 2002)

Higher Secondary in 12th – Nalanda College (1994 – 1994)

Secondary School in 10th – Adarsh High School (1992 – 1992)