Roles and responsibilitiesKeyResponsibilities:
To provide functional expertise of Technology Transfer activity. Responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes for products manufactured by Contract Manufacturing Organizations. This role will be responsible for handling of Tech transfers in line with Regulatory requirements independently.
This role will be responsible for coordinating technical-based activities at contract manufacturers. The job scope includes coordinating and supporting the activities related to:
- New product introduction
- Technology transfers including Site Transfers
- Technology transfers activities from R&D to outside CMOs
- Process validation planning and execution
- Process improvements
- Process documentation
- Process troubleshooting and process and product deviation root cause analysis.
- Regulatory dossiers documents submission and providing scientific response to the Queries.
Provide technical stewardship of manufacturing processes conducted at contract manufacturers.
Tech packs preparation and conducting Gap analysis on the Technology received from the Dossiers.
Conducting Technical assessment of new CMO sites.
Process design and Equipment finalization as per the suitability at Contract Manufacturing sites.
Comply with and support compliance to local and corporate GMP and HSE regulations.
Lead local projects for technology transfer, process changes, and new products introductions
Support manufacturing investigations and validations
Analyze and document process performance, process specifications, and change controls.
Experience with GMP regulated plants Technology Transfer.
Preferably working in manufacturing support or technical services role with particular emphasis on meeting Indian regulatory expectation
Pharmaceutical dosage formulation experience (Dry Granulation , Liquid Orals, Suspensions, Tablets and Capsules Granulation, compression, Coating, Capsules Filling and Fluid Bed Processor)
Active Pharmaceutical Manufacturing (API) evaluations.
Packaging evaluation based on the dossier information.
Validation strategy development, planning, and validation execution and documentation.
API, excipient, and final product sampling and testing.
Stability testing protocols review and critical process parameters monitoring.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Desired Candidate Profile
PG:M.Pharma - Pharmacy
HR Cornucopia Pvt. Ltd.
Cornucopia - A motif dating back to ancient Greece - it symbolizes abundance and prosperity. It is a magnificent horn overflowing with fruit, flowers and grain and it is emblematic of the horn possessed by the nymph Amaltheae, which could be filled with whatever its owner desired.
Thus it signifies our service 'Offerings in plenty' in the realm of Management especially Human Resource Management.
Contact Company:HR Cornucopia Pvt. Ltd.