Dr. Reddy’s Laboratories Pharma Job – Apply Now!
Team Member Qualification
Visakhapatnam Rural Mandal, India
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 (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 the final summary report.
- You will be responsible for the 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 Procedures), conducting investigations as a site investigation team member, and updating the Qualification status label.
- You will be responsible for periodic qualification schedule preparation, updating, and execution, as well as qualification of new or transferred equipment.
- You will also provide necessary assistance and support to various regulatory, internal, and external inspections.
Qualifications
Educational Qualification: B. Pharm, M. Pharm, B. Tech, M. Tech
Minimum Work Experience: 5 to 8 years of experience
Skills & Attributes
Technical Skills
- Experience in working with sterile product facility-related equipment qualifications such as Isolators, Autoclave, Vessel, Skids, etc., and validations such as media fill, cleaning validation, process validation, area qualification, and other miscellaneous qualifications.
- Expertise in preparation, review, and execution of documents, including URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ.
- Experience in handling incident investigations and CAPA processes.
- Experience in preparation and review of VMP and SOPs.
Behavioural Skills
- Effective communication skills for conducting training sessions and qualification activities.
- Attention to detail for preparing and reviewing documentation and reporting.
- Application of problem-solving skills in incident investigations and CAPA implementation.
- Efficient time management for meeting qualification schedules.
Link to original notification to apply: APPLY ONLINE HERE
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