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Home India Quality Assurance Assistant

Quality Assurance Assistant

Full time at VINS Bioproducts Limited in India
Posted on November 8, 2024

Job details

Company : VINS Bioproducts Limited Department: Quality Assurance Role: In-Process Quality Assurance (IPQA) Designation: Assistant Manager Job Description: Key Responsibilities: 1. Ensure compliance with cGMP, regulatory requirements, and company SOPs. 2. Monitor and control manufacturing processes to guarantee product quality. 3. Implement and maintain IPQA programs, including: - In-process sampling and testing. - Process monitoring and control. - Deviation management. - CAPA (Corrective Action/Preventive Action) implementation. 4. Collaborate with production, quality control, and other departments to resolve quality issues. 5. Review and approve batch records, SOPs, and other documentation. 6. Conduct audits, inspections, and training sessions. 7. Investigate and report quality incidents, OOS (Out-of-Specification) results. 8. Develop, implement, and maintain quality metrics and dashboards. 9. Manage and maintain documentation, including IPQA records and reports. 10. Participate in internal audits, customer audits, and regulatory inspections. Educational Qualification: 1. Bachelor's/Master's degree in: - Pharmacy - Chemistry - Biotechnology - Microbiology - Pharmaceutical Technology 2. Postgraduate diploma in Quality Assurance/Regulatory Affairs (desirable). Desirable Skills: 1. 3-5 years of experience in IPQA or related QA roles. 2. Strong knowledge of cGMP, FDA, EU, and other regulatory guidelines. 3. Excellent communication, analytical, and problem-solving skills. 4. Ability to work in a fast-paced environment. 5. Leadership and team management skills. 6. Familiarity with quality management systems (QMS) and ISO 9001. Location : Thimmapur (V) Kothur (M),Ranga Reddy (D) Telangana.

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