Job Description
* Calibration Activities i.e. all calibrations of the plant for cGMP, ISO 17025 purpose.
* Audits i.e. Conducts & Monitor cGMP, QMS, LMS, EMS audits
* International Regulatory Affairs i.e. Dossier submission for export purposes
* Compliance i.e. compliance of requirements as per internal, statutory & regulatory bodies
* Documentation Control
* Annual Product Review
Job Specification
1. Sound Knowledge of cGMP
2. Strong Technical & Analytical Skills
3. Well versed with WHO Guidelines
4. Proficient in Ms. Office*Validation Activities i.e. Cleaning Validation, Process Validations, Equipment Qualifications.
8 to 10 years of experience of working in pharmaceutical Quality Assurance department Education: MSc Chemistry or equivalent