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Job Description
Job role : Apply & maintain Quality management system all over the company to comply with international cGMP regulations and guidelines (EMA – WHO – pharmacopeias), EDA requirements and ISO standards.
Job Responsibilities
- Support with Quality Assurance manager QA Functions and to Ensure that GMP standards are in compliance with regulatory standards.
- Design, implement and improve QA systems including Validation, Documentation system, Compliance and In-process control.
- Ensure implementation of data integrity program within QA and on site operations level.
- Support Batch release function to ensure the overall assurance and disposition of products produced at the manufacturing site or by approved vendors.
- Preparation of monthly quality metrics to follow-up the performance of quality functions.
- Preparation for quality-related audits conducted by regulatory agencies.
- Interface with EDA regulatory Inspection and fulfillment of requirements
Job Requirements
- Bachelor degree of Pharmacy/Science .
- Not less than 15 years of Professional experience in Quality Management including (3 : 5 Years) in the same managerial position.
- Pharmaceutical Industry experience is a must .
- Master degree /PHD science is highly preferred .
- Strong Experience in leading external& internal audits and investigations also .
- In-depth knowledge of quality regulations and current industry practices( cGMP) .
- Excellent Leadership skills , Problem solving , Action- detail Oriented &Professional Decision making.
