Process Technology support, Machine assembly QA

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.

• 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.