Dr Reddy's Laboratories Limited
pharmaceutical
TeamMemberMSATinjectable
“Team Member MSAT injectable at Dr Reddy's Laboratories Limited. Skills: Cleaning Validation, Validation / qualification activities, Change controls, risk assessment, technology transfer activities. handle the cleaning Validation activities for Injectable manufacturing lines. Preparation & revision of CVMP”
What You'll Achieve.
accelerate access to affordable and innovative medicines; reach over 1. 5 Bn+ patients across the world by 2030; growing our core businesses and building for the future with sustainability at the core of our purpose and strategy
Industry & Context.
troubleshooting; root cause analysis; product impact assessments; non-conformance investigations; process changes/improvements; investigations for non-conformances
What They're Looking For.
Must Have
4 to 8 years of relevant experience, Bachelor of Technology or Bachelor of Engineering (Chemical engineer)/Bachelor of Pharmacy/Master of Pharmacy
What You'll Do.
handle the cleaning Validation activities for Injectable manufacturing lines
Preparation & revision of CVMP
Updating and Approval of CV Matrix
Preparation and Review of Cleaning Validation related Checklists
Protocol and Reports and its related assessments/training (as applicable)
Implementation of new applications related to Cleaning Validation
Provide support for troubleshooting
root cause analysis and product impact assessments for non-conformance investigations and process changes/improvements
Support for regulatory audits
review and approval of Change controls
Process comparision and risk assessment with respect to Validation / qualification activities
Co-ordination with CFTs (i. e. Production
QC) for tracking and execution and various documentation
Training of employees
Review change controls
and approve technical protocols
and product impact assessments related to product lifecycle management (LCM)
and risk assessments related to technology transfer activities
Support technology transfer activities for new products
and site-to-site commercial batches for injectable products
Support investigations for non-conformances (Incidents
Market Complaints) through root cause analysis and impact assessments
Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements
How You'll Work.
Team & Collaboration
Co-ordination with CFTs (i. e. Production, QA, QC) for tracking and execution and various documentation
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