Dr. Reddy’s Laboratories Ltd Recruitment for Quality Assurance Associate

Job summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing  IT infrastructure compliance and System life cycle Management of Equipment’s/Instruments/facilities/Utilities , ensuring CSV life cycle management as per 21 CFR part 11 and GAMP5  standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.

Roles & Responsibilities

Ability to review and approve validation deliverables and applicable procedures.

Ability to perform Project coordination, integration with CFT and Development team in delivering the objectives with compliance.

Provide Support for Development of Quality or IT policies and procedures in line with regulatory requirements related to IT Applications

You will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team.

Providing oversight for validation, engineering related GMP documentation including, but not limited to validation plans, SOPs, work instructions, protocols, summary reports and ensure consistency and compliance to regulatory requirements.

Ensuring adherence of requirement of SOPs and other procedures.

Manage proper functioning of Quality Assurance with continue support and co-operation with stakeholders in line with cGMP norms implementation with regulatory and statutory compliance.

Ensuring GMP compliance at Engineering functions of QA Biologics for Drug Substance (DS), Drug Product (DP), Equipment, Utility, System and GMP facility.

Part of QA validation team to support all aspects of Qualification and Validation Program, including qualification & requalification of equipment, utility, system and GMP facility.

Ensuring Commissioning Qualification, Modification/expansion, Requalification and revamping of equipment/utility/area and facility.

Ensure implementation of standards for cGMP, Quality and Safety in the GMP engineering operations of Biologics facility.

Coordinate, review, evaluate & approve protocols/reports of equipment, utilities, system and GMP facility.

Responsible to overlook on engineering services provided by OEM/Third parties.

Oversight on engineering (facility/utility) related issues inside GMP areas.

To highlight quality related problems in time, seek their resolution and providing QA expertise for assessing impacts on incidents and support investigations & troubleshooting, CAPA, Change requests, addendum, amendments report related to engineering processes.

Review, evaluation, approval of the change controls, incidents, investigations, CAPA and provide the QA comments and oversee the implementation respectively (as applicable).

Providing oversight, review, approval for validation, engineering related GMP documentation including, but not limited to; Site Master File (SMF), Validation Master Plan (VMP), Validation Plans, Standard Operating Procedures (SOPs), Work instructions, Protocol/Report, Summary reports and ensure consistency and compliance to regulatory requirements.

Providing guidance to stakeholders/functions on qualification/validation matters and to ensuring effective systems are maintained and improved as a part of continuous improvement plan.   

Provide support as needed in the regulatory audits/inspections.

Participate in risk assessment and evaluation process and review, evaluate, approve the risk assessment reports.

 You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor.

You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time.

You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records.

You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed.

Ability to review and approval of GXP and Non GXP tickets.

Ability to review and Approval of IT infrastructure compliance.

Ability to review and approval of Backup and restoration procedures and disaster management.

Ability to review and approve the GXP Assessment as per the GAMP 5 category.

Ability to review and approval of Quality risk Assessment accordingly allocation of mitigation plan and ensured compliance

Ability to review and approval of the Configuration specification, URS, Design Document (Software & Hardware ), IQ and OQ test script as per the validation plan.

Ability to perform Audit trial verification for Software, Equipment and Instruments

Familiar with 21 CFR Part 11, EUGMP Annexure 11 and other equivalent regulations

Computer System Validation: Review & approval of documentation related to IT systems during qualification/validation & lifecycle management.