Senior Executive - TSD

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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

Job Description

• Lead and execute process validation activities, including protocol generation, execution, and report writing for new and existing products.
• Provide technical expertise and troubleshooting support for manufacturing operations, resolving deviations, and implementing corrective and preventive actions (CAPAs).
• Participate in technology transfer activities for new products and processes from R&D to commercial manufacturing.
• Conduct process optimization studies to improve yields, reduce cycle times, and enhance product quality.
• Collaborate with cross-functional teams including Production, Quality Assurance, Quality Control, and R&D to ensure seamless execution of projects.
• Prepare and review technical documents, including batch records, specifications, and standard operating procedures (SOPs).
• Support regulatory submissions by providing necessary technical data and documentation.
• Stay updated with industry best practices, regulatory guidelines (e.g., cGMP, ICH), and new technologies in pharmaceutical manufacturing.
• Participate in investigations of critical quality events, out-of-specification (OOS) results, and customer complaints.

Job Qualifications

• Bachelor's degree in Chemical Engineering.
• 5-8 years of experience in a Technical Services, Process Development, or Manufacturing role within the pharmaceutical industry.
• Strong understanding of pharmaceutical manufacturing processes (e.g., solid oral dosage forms, sterile injectables, APIs).
• Proficient in process validation, technology transfer, and process optimization principles.
• Familiarity with cGMP, ICH guidelines, and other relevant regulatory requirements.