Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited.
Post : Team Member
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.
Job Description
• Must be aware of cleanroom practices, and behavior.
• Experience in sterile manufacturing equipment qualification is mandatory.
• Preparation and Execution of qualification protocols for Equipment’s, Autoclave, Tunnel, Filling and capping machine, Lyophilizer, Washing machine, bung processor etc.
• Preparation and Execution of qualification protocols for HVAC system.
• Review of HVAC designs documents, understand on RDS and all layouts of HVAC.
• Review of Utilities (WFI, PW, Compressed air, Nitrogen) designs documents like DQ, P &Id, process schematics, as built drawings etc.
• Preparation, review and execution of DQ, FDS, UTM.
• Preparation, review and execution of SAT, IQ, OQ, PQ documents (protocols and reports).
• Preparation and review of Risk assessment of equipment’s / systems.
• Review & compilation of raw data, relevant certificates, analysis test reports and preparation and review of final summary reports.
• Must follow GDP and ALCOA in all documentation, execution activities and compliance to 21CFR.
• Preparation, review and execution of SAT, IQ, OQ, PQ documents for Packing and inspection equipment’s (protocols and reports).
Candidate Profile
• Experience in working with sterile product facility related validations such as equipment validation, 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.
• 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.
Additional Information
Experience : 3 years
Qualification : M.Pharm
Location : Pydibimavaram - Andhra Pradesh
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Production - Sterile
End Date : 20th June 2024
See All Visakhapatnam Alerts B.Pharm Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
