Open to opportunities

Swarali Nikam

@swaralinikam

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Clinical Quality Assurance leader with 13+ years in GxP audits, QMS, and inspection readiness.

India

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What I'm looking for

I’m looking for an organization that offers open opportunities to enhance my skill and knowledge, while I contribute to the growth of the organization through independent GxP audits, strong QMS execution, and inspection-ready quality operations.

I’m a skilled Quality Professional with 13+ years in the Pharma and Clinical Research industry, focused on building and sustaining strong Quality Management Systems. I bring deep experience across GCP, GLP, GMP, and GVP auditing, including CAPA and deviation governance.

In my current and prior roles, I lead and support independent GCP/PV audits and internal audits spanning Clinical Data Management, Pharmacovigilance, Regulatory Operations, Clinical Operations, Biostatistics, and Medical Writing. I prepare and share audit reports, verify CAPA closure, and oversee risk-based approaches through coordination with subject matter experts and functional leads.

I also strengthen inspection readiness through QA support such as pre-inspection audit readiness, document reviews, and mock interview sessions. I’ve handled vendor qualification/re-qualification audits and represented QA during client audits and regulatory inspections, including USFDA, DCGI, ANVISA, and EMEA involvement.

Beyond audits, I own quality operations that keep systems compliant—SOP and work instruction document management, archival and retrieval, training records, and trend analysis using audit/CAPA trackers. I continuously invest in learning and credentials (including Certified CQI IRCA Lead Auditor for ISO 9001:2015) and earn recognition for consistent performance and engagement.

Experience

Work history, roles, and key accomplishments

Current

Assistant Manager - QA

Current

Tata Consultancy Services – Life Sciences

Dec 2020 - Present (5 years 6 months)

Led and supported independent GCP/PV audits and prepared/ shared audit reports with auditee teams. Reviewed/approved CAPA plans, verified CAPA closure, managed SOP/WI archival and revisions, and supported client audits and regulatory inspections including vendor qualification audits.

GCP Auditing Pharmacovigilance CAPA Management Deviation Management Clinical Data Management Audit Reporting

Sr. Executive - QA

Panexcell Clinical Lab Pvt. Ltd.

May 2017 - Mar 2020 (2 years 10 months)

Scheduled and conducted audits across Bio analytical, Clinical, Biostatistics, and Admin departments according to the audit plan, ensuring authorized systems and documents. Developed SOP training records, performed in-process and retrospective audits for BA/BE study support, and handled vendor audits while reviewing SOP adequacy and GLP/GCP compliance.

Biostatistics QA Audit Reporting Data Compliance Calibration & Validation Review

Research Associate

Glenmark Generics Research Centre

Dec 2005 - Sep 2011 (5 years 9 months)

Prepared for USFDA/ANVISA audits and supported day-to-day GLP compliance in the laboratory. Ensured data recording/reporting compliance to SOPs and protocols, performed quality control checks and online reviews of raw data, and managed archival of calibration and study documents.

GLP Audit Preparation Raw Data Review Online QC Checks

Research Associate

Max Fair Drugs & Cosmetics Pvt. Ltd

Jun 2004 - Dec 2005 (1 year 6 months)

Supported clinical trial documentation and materials, including case record forms, patient consent forms, draft protocols, and training manuals. Conducted clinical trial site audits to ensure compliance with study protocols and performed site audits for protocol adherence.

Case Record Form Support Clinical Trial Documentation

Quality Control Chemist

Vital Healthcare P. Ltd

Jun 2003 - Mar 2004 (9 months)

Performed in-process quality checks for injectable and packing materials and conducted water analysis, sample controls, and finished product testing as per pharmacopoeia and in-house specifications. Managed analytical standards and instrument calibration for HPLC, UV-spectrophotometer, pH meter, and polarimeter.

Quality Testing PH Meters Polarimetry