Manager - Validation (Production)

Job Role : Manager Validation (Production)

Location : Mohali

Responsibilities

Build a cohesive Team to support Validation activity in A- 41 Mohali Location

Collaborate for creating a robust CAPA program

Equipment and facility Validation of A- 41 Mohali Location, along with site Specific teams, which includes preparation, review and execution of protocols, and Master Validation documents.

Preparation, Review and execute protocols & reports in facility involving utilities, engineering, manufacturing operation & cleaning which shall include but not limited to HVAC, water, compressed air, process / packing equipment w.r.t. qualification & validation

To ensure that all qualification and validation protocols include critical steps / components which are to be checked and validated

To prepare, review & ensure compliance & written procedure w.r.t. validation function

To co-ordinate, review and manage the training needs and records as a department training coordinator (DTC).

To prepare validation planner for all utilities and equipments

To ensure the implementation of current good manufacturing practices

To look after the maintenance & improvement of product quality as per specification

To provide the training to personnel involved in validation activities as & when required

Participate in Quality Improvement projects

To ensure that all systems and equipments are validated as per the procedure / requirements and calendar

Responsible for Quality Management System compliance i.e., Handling of Deviation, Investigation, CAPA and CCR

Responsible to perform the internal and external audit as per the site specific procedure. Any other responsibility that may be assigned from time to time

Education Qualification : B.Pharm / M.Pharm

Experience : 12 to 15 Yrs (in Validation / Qualification)

Skills Required

Validation, Quality Management System, Qualification, Capa