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Ranjith Munukuntla

@ranjithmunukuntla

Quality Assurance Executive specializing in biologics and sterile manufacturing, driving data integrity, deviations/CAPA, and compliant release.

India

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What I'm looking for

I’m looking for pharmaceutical and life sciences/healthcare Quality and Regulatory roles with USFDA ,EMEA or gxp related opportunities, where I can drive sterile manufacturing , medical devices quality, data integrity, deviations/CAPA, and Market compliant batch release while supporting regulatory and QMS effectiveness.

I’m a Quality Assurance Executive with 7 years 6 months of experience in the pharmaceuticals industry, focused on sterile injectables, biologics (mAbs), API, and intermediate drugs. I lead quality and manufacturing operations to support current good manufacturing practices, while working across SAP MM and quality platforms like LMS, EDMS, and EQMS (with strong emphasis on 21 CFR Part 11).

I ensure compliance to ICH guidelines, GxP/CGMP, and coordinate USFDA/EU requirements for batch release, artwork, labeling, and non-compliance escalation. I’m known for driving Quality Management System effectiveness through deviation and CAPA execution using RCA and QRM, supporting APQR, and contributing to CSV/PQ validation documentation, data integrity, vendor qualification audits, and quality investigations across CMO sites.

Experience

Work history, roles, and key accomplishments

Current

Life Sciences Executive

Current

Fem Pharmaceuticals Ltd

Dec 2023 - Present (2 years 4 months)

Owned quality assurance activities for biologics and sterile injectables, including LIMS data integrity, deviation/OOS trend monitoring, and electronic batch record review. Coordinated CMO quality operations, CAPA/change control, and batch release/documentation aligned to US FDA and EU requirements.

LIMS Data Integrity Deviations And CAPA Trackwise

External Auditor (SCM)

Hetero Biopharma

May 2022 - Jan 2023 (8 months)

Performed SCM/vendor qualification and audit support, reviewing quality compliance procedures and batch release records for process validation support. Initiated APQR-related actions and ensured 21 CFR Part 11 documentation and auditing for validation effectiveness.

Supply Chain Compliance Batch Process Validation Audit Support Documentation Review

Manufacturing Quality Compliance

Lupin Limited

Jun 2020 - May 2022 (1 year 11 months)

Supported APQR/CPV activities including deviation handling with root causes, QMS/QRM follow-ups, and CSV documentation oversight. Conducted in-process sample collection and verification activities and supported validation execution, sterility/CCIT activities, and OOS investigations.

CSV Documentation Media Fill Validation Autoclave Line Clearance Cold Chain Monitoring

Manufacturing Quality Associate

Dr Reddy's Laboratories

Sep 2018 - Jun 2020 (1 year 9 months)

Managed manufacturing quality documentation and compliance, including SOPs, in-process deviation investigations, CAPA/APQR effectiveness tracking, and validation protocol preparation (DQ/IQ/OQ/PQ). Ensured compliance with CGMP and electronic record requirements (21 CFR Part 11) and supported aseptic processing activities including media fills, filter integrity testing, and change control.

CGMP Requirements SOP Management CAPA Change Control Calibration & Audit Readiness