Headline

Quality Assurance Officer| Injectable Pharmaceuticals | Market complaint | GMP | Deviation Management | CAPA | Investigations | QMS | Regulatory Compliance

About

Quality Assurance professional with approximately 2 years of experience in the injectable pharmaceutical industry, specializing in Quality Management Systems (QMS), deviation investigations, CAPA management, market complaints, product recalls, and quality documentation. Experienced in ensuring compliance with cGMP, Good Documentation Practices (GDP), and regulatory requirements while supporting continuous improvement initiatives. Skilled in root cause analysis, risk assessment, quality investigations, documentation review, and cross-functional collaboration. Possess a strong understanding of sterile manufacturing processes, data integrity principles (ALCOA+), documentation control, and pharmaceutical quality systems. Passionate about maintaining product quality, regulatory compliance, and patient safety while continuously expanding expertise in pharmaceutical quality and compliance.

Location

Palghar

Work experience

Officer at Samrudh Pharmaceuticals Pvt Ltd, Jul 2024 - May 2026 · 1 yr 11 mos, Palghar, Maharashtra, India, Quality Assurance Executive | Injectable Pharmaceuticals • Managed and investigated quality deviations, ensuring timely closure through effective root cause analysis and CAPA implementation. • Reviewed and approved deviation reports, CAPAs, market complaints, and quality investigation documents. • Participated in Change Control management, risk assessments, and quality impact evaluations. • Ensured compliance with cGMP, SOPs, Data Integrity requirements, and regulatory guidelines. • Coordinated with Production, Quality Control, Engineering, and Warehouse departments for investigation and corrective action activities. • Supported internal audits, regulatory inspections, and quality system compliance initiatives. • Reviewed batch manufacturing records and quality documentation for accuracy, completeness, and compliance. • Assisted in trend analysis of deviations, complaints, and CAPAs to identify continuous improvement opportunities. • Contributed to maintenance and improvement of Quality Management Systems (QMS). • Supported training and implementation of quality procedures across manufacturing operations. Coordinated and supported product recall activities, including investigation, impact assessment, regulatory compliance, and recall documentation. • Participated in market complaint investigations and product recall evaluations to ensure patient safety and compliance with applicable regulatory requirements. • Assisted in product retrieval, reconciliation, recall effectiveness checks, and preparation of recall reports.

Intern at Mac-Chem Products India Pvt. Ltd., Jun 2024 - Jul 2024 · 2 mos, Palghar, Maharashtra, India, Gained exposure to pharmaceutical Quality Assurance systems and Good Manufacturing Practices (GMP). Learned principles of Data Integrity, including ALCOA+ requirements and regulatory expectations. Developed understanding of documentation control practices, document lifecycle management, and Good Documentation Practices (GDP). Acquired basic knowledge of various pharmaceutical departments, including Quality Assurance, Quality Control, Production, Warehouse, Engineering, and Regulatory Affairs. Developed awareness of data privacy and compliance concepts.

Education

Bachelor of Pharmacy, Aldel Education Trusts St John Institute of Pharmacy At Vevoor Palghar Tal Palghar Dist Thane

Jr. College, Science, Tarapur Vidya Mandir