Executive - Manufacturing, Science & Technology (NOS)

Job Summary

Exective is responsible for overseeing all process optimisation, Trail & validation activities in compliance with GMP, SOPs, and global regulatory guidelines (Health Canada, FDA, EU). The role includes supervision, training, and development of personnel involved in  execution and protocol & report preparation, with accountability for work scheduling, project prioritization, and timely resolution of roadblocks.

Job Responsibilities

Site technology Transfer:

1. Prepare, review, and update standard operating procedures and Validation Master Plan.
2. Coordinate and review quality risk management (QRM).
3. Prepare and review cleaning validation protocols and reports. Perform cleaning validation product risk assessments to identify worst-case molecules for cleaning validation.
4. Cleaning validation related activities and e-Residue software application activities.
5. Prepare and review PDE changes.
6. Prepare and review of quarterly and annual monitoring reports for cleaning validation.
7. Prepare for regulatory audits and ensure compliance.
8. Prepare and review Annual Product Quality Review (APQR) and data trending for products (3B).
9. Review and approve process validation protocols and reports for demonstration, optimization, qualification, and verification batches.
10. Prepare and review process validation and APQR activities in QMS Track wise.
11. Conduct QA assessments for change control, action items, and review MDoc from various departments in QMS Track wise.
12. Coordinate periodic self-inspection activities.
13. Review of Technical data package for site transfer products.
14. Review of tooling drawings of site transfer products.
15. Provide support for manufacturing license application of site transfer products.
16. Preparation of following technical documents with respect to site transfer:

• Cross contamination quality risk assessment report for new product introduction at ARPL.
• Master Formula Records
• Technical Risk Evaluation of Products transferred from Apotex manufacturing sites to Apotex research private limited (ARPL), India
• Process Optimization Protocols & Reports
• Process Demonstration Protocols & Reports
• Hold Study Protocols & Reports If any
• Placebo Formulation sheets
• Technical Risk Assessment
• PPQ Protocols & Reports
• CPV Protocols & Reports

1. Monitoring of Process Optimization/Process demonstration/PPQ batches.
2. Ensure archival of Process Optimization/Placebo batch documents to QA.
3. Any other activities as assigned related to site technology transfer.

Technology transfer of New products:

1. Preparation of the following technical documents with respect to Technology transfer of new products
• Cross contamination quality risk assessment report for New product introduction at ARPL.
• Master Formula Records
• Technical Risk Evaluation of new products
• Process Optimization Protocols & Reports
• Process Demonstration Protocols & Reports
• Hold Study Protocols & Reports If any
• Placebo Formulation sheets
• Technical Risk Assessment
• PPQ Protocols & Reports
• Nitrosamine Risk Assessment Report
• CPV Protocols & Reports
2. Monitoring of Process Optimization/Process demonstration/PPQ batches.
3. Any other activities as assigned related to New product launch.

Manufacturing process support:

• Troubleshooting of processing issues for commercial batch manufacturing at shop floor.
• Manufacturing process support in the event of any issues which are unplanned and require immediate resolution.
• Draft technical summaries, investigation reports, or SME responses following QMS Track Wise Investigation procedures.

Job Requirements

• Education:
  • Minimum Master Degree in Pharmacy (Pharmaceutics) 

• Knowledge, skills and abilities :
  • Should have knowledge of process development, MS&T and Technology transfer on Solid dosage forms for regulated markets like USA, Europe, Canada and Australia is essential.
  • Should have a good understanding of Product development process along with scale-up knowledge of the product and Process Validation.
  • Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet
  • Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
  • The willingness to upgrade knowledge/education on an on-going basis.

• Experience
  • Minimum 3 to 7 years of Experience in the MS&T