Apprentice

Piramal Pharma Ltd; Ahmedabad District; On-site; INR 112,000 - 279,000; Full time

Job summary

Piramal Pharma Solutions in Ahmedabad is seeking an Apprentice to support formulation development, GMP batch execution, and technical documentation for NCE and generic projects. You will coordinate with cross-functional teams to ensure GMP, GDP, QMS and EHS compliance and participate in technology transfer and routine R&D lab activities.

The role involves assisting in development and manufacturing of GMP batches, preparing technical documents, and contributing to audits and training of staff,

Qualifications

• Support formulation development and GMP batch execution.
• Ensure compliance with GMP, GDP, QMS and EHS requirements.
• Assist in technology transfer and routine R&D laboratory activities

Responsibilities

• Formulation development of NCE projects, generic projects and line extension projects.
• Preparation/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.
• Preparation/review of technical documents, including MFC, BMR, BPR and Stability protocol following GDP.
• Representation in departmental audit
• Follow GxP (GMP, GDP) for all processes and train subordinates to follow the same.
• Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition.
• Preparation and/or review of technology transfer documents and transfer to manufacturing site when required
• Preparing/reviewing of QMS includes change control, deviation, SOPs and OOS
• Communication with cross-functional team and client via mails, meetings and oral communication
• Provide training on SOPs, technology, guidelines and project activities
• Performing calibration and maintenance of R&D instruments and equipment
• Procuring materials and machines change parts related to concern projects
• Maintain safe and hygienic condition in respective department
• Ensuring PPE use during batch execution
• Attending training related to FD, EHS, QA or any department
• Ensure comply with EHS requirements while working in FD lab and Pilot plant
• Support to proposal preparation for upcoming new projects
• Support to any additional responsibility within or other department as needed

Skills

Formulation development

GMP batch execution

Technical documentation

Technology transfer

Job description

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

Apprentice

Job Description

Support formulation development, GMP batch execution, and technical documentation for NCE, generic, and line extension projects. Ensure compliance with GMP, GDP, QMS, and EHS requirements while coordinating with cross-functional teams. Assist in technology transfer and routine R&D laboratory activities

• Formulation development of NCE projects, generic projects and line extension projects
• Preparation/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 of assigned product.
• Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP.
• Representation in departmental audit
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
• Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition.
• Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required.
• Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS
• Communication with cross-functional team and client via mails, meetings and oral communication
• Provide training on but not limited to SOPs, technology, guidelines and project specific activities
• Performing and/or supervision calibration and maintenance of R&D instruments and equipment
• Procuring 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, QA or any other department (if applicable)
• Ensure comply with EHS requirements while working in FD lab and Pilot plant.
• Support to proposal preparation for upcoming new projects
• Support to any additional responsibility/activity within or other department as and when required