Quality Assurance Manager/Executive/ Regulatory Affairs (WHO / US FDA /EU GMP facilitated Steroids and Hormones API Manufacturing Pharmaceutical Company located at Kalol Gujrat)
Asst/Deputy/ Manager --Quality Assurance/Regulatory Affairs
Responsible for leading the quality assurance functions within the Organization. This position has the overall responsibility to oversee
The maintenance of product quality and compliance through the Quality Assurance function as well as management of the Quality Management System and compliance processes.
The incumbent will provide strategic leadership and coordination of These key functions to ensure that the short term and long term Objectives of the company are met
Job Interactions & Interface
Internally this position interacts with all departments within the Organization and with management and employees India. Externally this Position interacts with government authorities, industry organizations, Consultants, vendors, legal counsel and health care professionals.
Manage the Quality Assurance group in the development revision and Implementation of Standard Operating Procedures (SOPs) as required.
Ensure compliance (GMP, GXP) with appropriate SOP's in line with Practice & various Health Regulatory Authorities and guidelines.
Liaise with peers in other operating companies to share experience and Best practices
Support and lead QA Specialist qualified person for internal quality Compliance matters
Support and lead the QA Specialist to liaise with customers and Regulatory authorities regarding quality matters, including hosting Inspections and responding to observations.
Support and lead the Compliance Specialist for QMS and other compliance Programs
Handling of product complaints
Qualification & Experience
BSc M.Sc. B/M. Pharm, from a reputed college with 5- 15 years of Experience in API or Bulk drug industry
Experience in Steroidal, Hormonal and Vitamin API~s will be preferred.