Job Responsibilities:
Prepare, review, and execute qualification protocols (User Requirement Specification, Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification) for equipment, utilities, and facilities.
Coordinate with Engineering, Production, and QC for scheduling and execution of qualification activities. Review and approve qualification reports and ensure deviations, if any, are investigated and closed.
Prepare and execute Validation Master Plan (VMP) for process, cleaning, analytical method, and computer system validation.
Author, review, and approve process validation and cleaning validation protocols and reports.
Coordinate execution of validation batches with Production, QC, and QA.
Identify training needs based on job role, SOP revisions, deviations, and audit observations.
Prepare and implement the annual training calendar/plan.




Conduct/coordinate GMP, SOP, and job-specific training sessions for employees.
Prepare the annual APQR schedule for all marketed products.
Compile data related to batch manufacturing, in-process and finished product testing, yield, deviations, OOS/OOT, change controls, market complaints, and returns.
Perform trend analysis of critical quality parameters and process performance.

Candidate criteria:

Fluent in English
Willing to relocate to Navsari or presently staying near Navsari
Must have experience in a pharmaceutical formulation company.
Proficiency in MS Office / relevant QMS software.

Education: M.Sc. / B. Pharm / M. Pharm.

Experience: Having 5 to 7 Years in Formulation Pharmaceutical.

📌 Quality Assurance Executive (Navsari)
🏢 Meridian Enterprises
📍 Navsari