shara Daram

Deputy Manager at Lucid Laboratory Pvt Ltd

• India - Hyderabad
• My current job since August 2013

• To prepare new SOP, initiating SOP change control, SOP reviewing, Proactively focus on Quality system improvements, instrument URS, IQ, OQ, PQ, and validations.
• Supervision and management of Biological testing lab and staff training Review project protocols & reports.

• To maintain Management System Requirements of Microbiology department and to implement systems as per ISO/IEC 17025 - 2005, NABL and other statutory bodies.

• Participate, coordinate departmental ILC. IQC samples preparation and plan.
• Calibration of all equipments as per schedules and performing the internal calibration of the equipments.

• Responsible for media and reagents inventory, verification on receipt and proper storage
• Maintaining the reference culture and its viability and its purity Performing the growth promotion tests for microbial media.
• Technical support for business development department
• To identity and procure relevant cultures 1 standards 1 reagents etc.
• To identify, initiate and implement corrective preventive actions relevant to Microbiology department.

• Perform testing of various samples like food, water, aurvedic products, pharma samples, endotoxin tests, cosmetics, fibres, leather, wool, disinfectant fluids, electronic items as per IS.ISO.USP, BP, IP, EP, FDA, JSS 55555, JSS 0256, MIL STD, IEC 60068
• Validatin of methods and parameters as per client requirement.

• Performing customer complaint investigations, cGMP Documentation, cGMP Implementation
Implementation of GMP concepts., Facing customer audits.

• Reviewing of QA related documents, Implementation of ISO 15189:2007/17025:2005 Investigating customer complaints and requiremtns, CAPA implementation, Documentation control, Archival procedures, Preparing new protocol and validation.

• As a Quality Control Microbiologist to maintain Final Product Micro Analysis, Online Microanalysis, Self life analysis of product. Air monitoring in filling section. C.I.P & G.M.P. H.A.C.C.P implementation and its control, Documents and reporting, Housekeeping and Hygienic Practice. Raw Material Analysis. Group discussion to Implementing the quality of the product.

Professional Snapshot

As a Senior Executive Microbiologist cum Section In-Charge, having profound experience in Isolation, Identification & Enumeration of all Food poisoning bacteria in different commodities as per ISO, ISI, BAM, APHA, AATCC, EU compendium for the microbiological examination.

Food samples:
Total Aerobic count-ISO 4833-2003, Yeast $ mold-ISO 7954-1987, Total coli forms (MPN) ISO 4832-1991, E.coli ISO 7251-1993, S.aureus ISO 6888-1000, Salmonella ISO 6579-2002, Shigella ISO 21567-2004, V.cholerae, parahaemoliticus ISO 8914-1990, Clostridium perfringens count-ISO 7937-2004, Listeria monocytogens, Bacillus cereus, Aerobic $ anaerobic spore former, Thermophilic acidophilic bacteria, Flat sour organisms’ (FDA-BAM 2001) 8th Edition and Compendium for the microbiological examination.


Water samples:
Standard plate count, Heterotrophic plate count Thermophilic count, Proteolitic and lipolytic organisms, Slime forming organisms, Coli form count (MPN), Faecal coliforms, E.coli, As per IS 1622:2003, IS 10500-1998, APHA 21st edition 2005. All Microbiological parameters in Packaged drinking water as per IS 14543:2005.

Pharma :
Raw material and final products drug sample analysis as per the IP, BP.USP microbiologically. Sterility Testing, Culture Maintenance, MLT

Soaps & Toilet prepations, disinfected fluids:
Antimicrobial bar soap efficacy test, Antibacterial property IS 11479 - 2001
Rideal walker coefficient IS 1061-1997, Bacterial activity En 1276.
Air & swab samples: Indoor air Quality by using Anderson sampler and to check the Sanitary samples by using swab method As per ISO and BAM
Instruments:
Anti fungal tests and fungal resistant tests in all electrical and electronics instruments as per P55555 methods.