Senior Research Associate -FD

Piramal Pharma Solutions; Ahmedabad District; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Piramal Pharma Solutions is a CDMO offering end-to-end development and manufacturing across the drug life cycle. The Senior Research Associate - FD will deliver projects within timelines, develop and manufacture solid oral and other dosage forms, and ensure adherence to GMP, GDP and GDP standards while driving QbD principles.

The role involves preparing and reviewing technical documents, supervising scale-up and pilot batches, and coordinating with cross-functional teams and clients to meet

Qualifications

• Delivery of project within timelines, cost and specifications.

Responsibilities

• Execution of NCE projects, generic projects and line extension projects using QbD principle.
• Preparation and/or review of literature summary and development report to the assigned product.
• Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches to the assigned product.
• Preparation and/or review of technical documents like MFC, BMR, BPR and Stability protocol etc. following the GDP.
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up and pilot batches in pilot under GMP condition.
• Preparation and/or review of technical documents like product development report, batch manufacturing record, technology transfer documents and transfer of technology to manufacturing site, if required.
• Preparing/reviewing/approving the QMS documents like change control, deviation and out of specification.
• Communicating with cross-functional team and client via mails and meetings.
• Participating and representing in departmental audit.
• Preparing and reviewing department relevant SOPs.
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment.
• Procuring/ indenting materials and machines change parts related to concern projects.
• Maintain safe and hygienic condition in respective department.
• Ensuring the use of personal protective equipment whenever required during batch execution.
• Attending training related to FD, EHS and QA (if applicable).
• All generated waste to be sent to concerned person and must be comply with EHS requirements.
• Communicating and interacting with international and national clients.
• Preparing and/or reviewing of proposals for upcoming new projects.
• Annual performance review and goal setting of team members.

Job description

Job Description:

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Research Associate -FD

Job Description

Delivery of project within timelines, cost and specifications. Formulation development and manufacture of solid oral and other dosage form.

• Execution of NCE projects, generic projects and line extension projects using QbD principle.
• Preparation and/or review of literature summary and development report to the assigned product.
• Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches to the assigned product.
• Preparation and/or review of technical documents like MFC, BMR, BPR and Stability protocol etc. following the GDP.
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up and pilot batches in pilot under GMP condition.
• Preparation and/or review of technical documents like product development report, batch manufacturing record, technology transfer documents and transfer of technology to manufacturing site, if required.
• Preparing/reviewing/approving the QMS documents like change control, deviation and out of specification.
• Communicating with cross-functional team and client via mails and meetings.
• Participating and representing in departmental audit.
• Preparing and reviewing department relevant SOPs.
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment.
• Procuring/ indenting materials and machines change parts related to concern projects.
• Maintain safe and hygienic condition in respective department.
• Ensuring the use of personal protective equipment whenever required during batch execution.
• Attending training related to FD, EHS and QA (if applicable).
• All generated waste to be sent to concerned person and must be comply with EHS requirements.
• Communicating and interacting with international and national clients.
• Preparing and/or reviewing of proposals for upcoming new projects.
• Annual performance review and goal setting of team members.

Any other task or assignments given related to project by management or organization for product development and organization improvement.

Requirements