Manisha Sawant

Results-driven Microbiology professional with over 13 years of experience in Pharmaceutical Quality Control and Microbiology across sterile formulations, API, and finished dosage forms. Experienced in leading microbiology operations, laboratory compliance, method validation, environmental monitoring, water systems, sterility assurance, and regulatory documentation. Proven expertise in handling regulatory inspections including USFDA, MHRA, and ANVISA audits.

Strong leadership abilities with extensive knowledge of cGMP, GLP, data integrity, quality systems, laboratory investigations, and microbiological compliance.

Senior Executive – Microbiology - Pharmaceutical Manufacturing Plant, Dombivli - Dombivli

(2023-05)

• Manage microbiology laboratory operations ensuring compliance with cGMP and regulatory requirements.
• Review microbiological test results and laboratory documentation.
• Perform sterility testing, bacterial endotoxin testing, environmental monitoring, and water analysis.
• Conduct microbial trend analysis and prepare monthly, quarterly, and annual reports.
• Support validation activities including Sterility Method, BET Method, MLT Method, and Autoclave Load Validation.
• Maintain microbiological reference cultures and laboratory records.
• Coordinate calibration and qualification of microbiology laboratory instruments.
• Participate in internal and external regulatory audits.

Section Head – Microbiology (Sterility Section) - Indoco Remedies Ltd. - Goa

(2014-01 - 2016-03)

• Led microbiology activities for sterile formulation manufacturing.
• Managed sterility testing and environmental monitoring programs.
• Supervised microbiology personnel and laboratory operations.
• Prepared and reviewed SOPs and microbiological documentation.
• Supported regulatory inspections and validation programs.
• Ensured laboratory compliance with GMP and data integrity requirements.

Microbiology Section Head - Choksi Laboratories Ltd. - Verna, Goa

(2012-08 - 2013-05)

• Managed microbiological testing activities.
• Reviewed analytical data and ensured compliance with quality standards.
• Performed microbial limit testing and validation studies.
• Coordinated documentation and laboratory investigations.

QC Officer - Geno Pharmaceuticals Ltd. - Goa

(2012-01 - 2012-08)

• Conducted microbiological testing of finished products and APIs.
• Performed environmental monitoring and water testing.
• Maintained laboratory documentation and records.

QC Officer - Cosme Pharmaceuticals Ltd. - Goa

(2007-11 - 2012-01)

• Performed microbiological analysis of pharmaceutical products.
• Conducted preservative efficacy testing and antibiotic assays.
• Supported stability studies and cleaning validation.
• Assisted in microbiological method validation.

M.Sc. - Microbiology - Vinayaka Mission University (2012)

B.Sc. - Microbiology - Goa University (2005)

HSSC - Goa Board (2002)

SSC - Goa Board (2000)