Gopi A

To seek a role in a dynamic QA team where I can apply my knowledge of GMP compliance, documentation review, and process improvement to support product quality and regulatory standards in manufacturing and lab environments.

Quality Assurance Officer - GLOBAL CALCIUM PRIVATE LIMITED, HOSUR - HOSUR

(2024-05)

Global Calcium Private Limited is a globally certified manufacturer of APls and mineral actives, approved by regulatory bodies such as USFDA, EU-GMP. COFEPRIS, and 150 9001:2000. The company is known for its strong focus on quality, innovation, and regulatory compliance across international markets.

• Ensure smooth product changeovers by providing timely line clearance and verifying compliance with GMP standards.
• Actively monitor shop floor operations to uphold GMP, cGMP, and regulatory requirments.
• Maintain high standards of documentation by following ALCOA++ principles for Good Documentation Practices (GDP)
• Review Batch Manufacturing Records (BPR) and Lot Manufacturing Records (LMR) to ensure accuracy and completeness.
• Oversee purified water systems and ensure they meet quality and safety standards.
• Inspect and monitor raw materials and returned goods to verify quality and compliance.
• Prepare temperature and humidity mapping reports for designated periods to support environmental control.
• Assist in compiling Annual Product Quality Review (DATA ENTRY) reports to evaluate product performance and compliance.
• Support internal audits and external inspections by regulatory bodies.
• Collaborate with cross-functional teams to resolve quality issues and implement corrective actions.
• Keep QA documentation and SOPs updated in line with current regulatory guidelines.

Bachelor of Pharmacy (B.Pharm) - PSV College of Pharmaceutical Science and Research, Orappam, Krishanagiri (2018 - 2022)