The candidate will be responsible for continuing FDA license, provide guidance/ training to improve process related to Granulation & compression, troubleshoot for process related challenges at Inhouse as well at customer site. He should be able to test the machine performance as per Protocol.
Carryout documentation related work and maintain records for process optimization Aids the level above in setting up trials and tests as required at various stages and conducting customer trials at the factory.
Customer visits to resolve challenges if any related to the process.
Market survey
Gather information related to challenges faced by customers for resolution
GAP analysis and RCA and Solution implementation at site.
Suggest customers for formulation changes and inform design for design-related challenges wherever required.
Carryout in-house validation and at site.
Getting reference letters.
Facilitate sales by demonstration of features of machines at site.
Training customers at site and internal team.
Preparation of formulation data bank and publish
Inhouse machine testing as per protocol.
Continuation of FDA license and related audits.
Qualifications and Education Requirements:
Bachelor's in pharmacy (B. Pharm)
8-10 years of relevant experience in the pharma industry
(Experience in Pharma production/ R & D) Key Competencies Required:
Technical:
Basic understanding of:
Product related characteristics
Granulation process & trouble shooting
Compression process & trouble shooting
Coating process & trouble shooting
Characteristics of different molecules
Advanced understanding of Critical formulations
MUPS Formulation Processing & Compression
Bilayer Process, Compression & Trouble shooting
Compression Machine related knowledge & Trouble shooting
FDA regulations, Audits & compliance
Validation & Documentation
Behavioral:
Innovation
Cross-functional Team Working
Quality and service orientation
Delivering consistent results
People development
People development for Multiskilling, training for knowledge enhancement, personal development.
Key Result Areas
Effective Machine testing in order to avoid challenges at site.
Provide effective solutions at inhouse as well at customer site for the reported challenges.
Demonstrate machine performance at site.
Continuation of FDA license.
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