Team Member - Qualification

Job Summary

We are looking for an individual for the qualification team to manage the documentation and execution of qualification activities, including the preparation, review, and execution of various qualification documents. The ideal candidate will oversee new project-related tests, review and compile raw data, and ensure compliance with validation master plans and SOPs. Additionally, responsibilities include implementing corrective and preventive actions, conducting incident investigations, and providing support during regulatory inspections.

Roles & Responsibilities

• You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents.

• Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems.

• You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).

• You will review and compile raw data, relevant certificates, analysis test reports and

• preparation and review of final summary report.

• You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation.

• Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval.

• You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification.

• As part of your role, you will prepare and review VMP (Validation Master Plan).

• You will conduct training for employees and external vendors as a qualified trainer.

• Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label.

• You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment.

• You will also provide necessary assistance and support to various regulatory, internal and external inspections.

Educational Qualification

B. Pharm, M.Pharm, B.Tech, M.Tech

Minimum Work Experience

8 to 12 years overall experience

Benefits Offered

At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

" Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

For more details, please visit our career website at https://careers.drreddys.com/#!/"