GM-DGM-Production

☞ Star Vision Placement

View: 106

Update day: 06-05-2024

Location: Bhiwani Haryana Bhiwadi Rajasthan

Category: Production / Operation Maintenance

Industry: Recruitment Staffing

Position: Head/VP/GM-Production/Manufacturing/Maintenance

Job type: Full Time, Permanent

Experience: 15 - 20 years

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Job content

Job Descripation :-
Ensure that all the functional / operational and safety procedures are adhered during the routine working at R&D to ensure compliance
Performing Literature and Patent Search for API and formulation to understand the critical requirements for product development
Review and Approval of Standard Operating Procedures to define and harmonize the development process at R&D
Cross-functional coordination for the qualification of API and/ or excipients for use in the formulations as per regulatory and procedural requirements
Development of different types of dosage forms for Regulated Markets like USA, Europe and Canada, preferably Parenteral / Injectable Product Development to enable filing of ANDAs/ Dossiers
Planning, Support and Execution of lab scale development batches as per GSP/ GLP requirements for stability data generation at R&D
Planning of various activities and co-ordination with Cross Functional Teams for procurement of API, excipients, equipment/ instruments for the developmental activities
Product development using Quality by Design (QBD) and Design of Experiments (DOE) approach and exhibit batches completion as per stipulated project timelines
Review and approval of various documents like Product Development Report, and other Scientific Reports like Hold Time Study Report, Material Compatibility Study Report, Filter Compatibility Report, Reconstitution Study Report, MMRs, MPRs, Stability Protocols and Reports
Coordinating with various departments like Purchase (SCM), Analytical Development, Production, Regulatory Affairs, Quality Assurance etc
Scale-up and Technology Transfer of developed products to shop floor for smooth launching of new products Periodic review of the developmental work and guiding the team members in planning and execution of project as per stipulated timeline
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Deadline: 20-06-2024

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