Senior Executive - TSD

Job Description:

Responsibilities

• 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.

Qualification & Experience

• 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.