6 Job openings found

  Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing. Key Responsibilities Quality Systems & Compliance Implement, ...

Good Knowledge of USFDA/ EDQM /ANVISA / and all other regulatory & CGMP awareness. Strategic oversight and leadership: Develop and implement the company's quality management system (QMS) and strategy, aligning it with business objectives. This includes overseeing all aspects of quality operations and managing the QA and QC departments. Regulatory compliance: Ensure ...

Position:        Plant Head (Bhopal) Location:       Bhopal Experience:   20 - 25 Years Industries:    Pharma Responsibilities: Lead end-to-end technical operations including biologics manufacturing, sterile injectables, formulation & fill-finish. Drive cGMP compliance, data integrity, technology transfer, process optimization & commercial scale-up. Ensure readiness for global regulatory inspections including USFDA, EU GMP, MHRA, WHO, ANVISA etc. Oversee plant administration, ...

The job description is as below: Purpose of the RoleTo ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements. Key Responsibilities 1. Regulatory Query ManagementReceive, log, track, and respond to regulatory queries, including US ...

Position:          Dy. Manager - Quality Location:         Vapi Experience:      8 - 10 Years Industries:       Pharma API  Responsibilities: Quality Management System (QMS)   Establish, implement, and maintain an effective Quality Management System in line with cGMP, ICH, USFDA, EU-GMP, WHO, and other regulatory requirements. Ensure compliance with SOPs, policies, and ...

Position:          Sr. Officer/Executive - QC Location:         Bhimpore - Daman Experience:      5 - 8 Years Industries:       Medical - Device Responsibilities: Analytical Instrumentation & Testing Perform analysis and troubleshooting of HPLC, GC-HS, FT-IR, UV, Dissolution Apparatus, and other laboratory instruments. Ensure the proper calibration and maintenance of laboratory instruments as per SOPs. Review ...