Executive

About the Role

We are looking for an Executive in Process Development (Technology Transfer) to move drug products from R&D to commercial manufacturing, and between manufacturing sites. You will plan and run batches and handle the documentation that supports regulatory filings, all in line with cGMP.

Responsibilities

• Facilitate technology transfer of drug products from R&D to the manufacturing site, and from one site to another.
• Plan and execute experimental, processed/unprocessed placebo, scale-up, pre-validation, exhibit and qualification batches.
• Prepare and review batch protocols and reports for experimental, scale-up and pre-validation batches.
• Review master BMR/BMI, process qualification protocols and reports, and RM, IP and FP specifications.
• Prepare and review elemental impurity and nitrosamine risk assessment reports.
• Review hold time studies, APQR, transportation studies, equipment qualification and cleaning validation documents.
• Review stability protocols for exhibit, commercial and development batches.
• Initiate SAP input data requests (BOM/Recipe) for placebo, exhibit and commercial batches.
• Coordinate with R&D, Manufacturing and GSCO/GSCM so that RM/PM are available on time.
• Handle QAMS: change controls, deviations and CAPA.
• Review investigations for OOS, OOT, OOE, IPOOS, deviations and market complaints.
• Support regulatory audits and inspections, and audit compliance.
• Contribute to process improvement projects, yield proposals and process flow charts.
• Provide complete documentation to QC, QA and RA for tech transfer, regulatory filing and product launch.
• Follow cGMP, GDP and EHS requirements, and train team members on relevant SOPs.

Qualifications

• M. Pharm / B. Pharm

Experience

• 7 to 8 Years

Required Skills

• Technology Transfer, Scale-up, Exhibit Batches, Process Validation, Risk Assessment, QAMS, OOS/OOT Investigation, SAP, cGMP, Regulatory Audits

Salary Range

• up to 9 LPA