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.

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.