Asst Manager / Manager : Quality Assurance - Pharma

Were hiring a Quality Assurance Manager for Pharma Vertical join our team and deliver excellence!

Requirement is on the rolls of Cotecna Life Sciences India Pvt Ltd . (Erstwhile Geochem Laboratories)

Role & responsibilities

• Establish, implement & maintain Quality Management System as per current GxP activities including ISO/ IEC 17025: 2017.
• Make independent and timely GxP decisions concerning quality and compliance requirements
• Host and support regulatory and customer audits.
• Train and coach staffs on GxP regulations. Manage GxP and ISO documentation system along with training program.
• Establish and align Quality Assurance SOPs to guidelines and current practices.
• To ensure that laboratory participates in various Proficiency Testing or inter laboratory comparisons conducted time to time.
• Assess quality and compliance risks proactively to prevent recurring issues or potential risks to the Lab operations.
• Plan an annual internal audit program, perform internal audits and follow-up on corrective actions.
• Handle deviations, Out-of-Specification (OOS) investigations, customer complaints, and Corrective and Preventive Actions (CAPA) in a timely manner.
• Manage the change control system.
• Identify of deviations from the management system or from the procedures for performing laboratory activities and initiate actions to prevent or minimize such deviations.
• Report to laboratory management on the performance of the management system and any need for improvement
• Ensuring the effectiveness of laboratory activities.
• Assist in the review of Quality Agreements with customers.
• Coordinate the Management Review Meetings with Management and escalate quality issues to management in a timely manner.
• Any other job assigned time to time by the Management.

Qualification : M.Sc(Chemistry)

Experience : 10 to 15 years

Work Location : Digha(Navi Mumbai)