Senior Executive, Manufacturing, Science & Technology

Job Summary

Site technology Transfer:

1. Internal product technology transfers from an Apotex manufacturing site to Apotex research private limited (ARPL), India.
   • Technology transfer of  New products:
     
     
2. New product transfer from formulation development to commercial scale.
   • Manufacturing process support: Technical support for the trouble shooting of processing issues in Commercial batch manufacturing.
   • Product Life cycle Management (PLCM) : Technical support to ensure robustness of product/process through out its life cycle.
   • Supplier driven changes (SDC) : Change or addition of a source or supplier driven change in raw material (API & Excipients) manufacturing process for existing commercial products.
   • Documentation: Documentation support for the MS&T activities
   • All other relevant duties as assigned.
   • Coordinate, document, and validate manufacturing and packing activities, monitor validation requirements, and support regulatory submissions and product launches/Site transfer.

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 activiteds 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 Trackwise.
11. Conduct QA assessments for change control, action items, and review MDoc from various departments in QMS Trackwise.
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 TrackWise Investigation procedures.

Job Requirements

Product Life cycle Management (PLCM):

1. Preparation of the following technical documents with respect to PLCM products:
   1. Technical summary report
   2. Technical Investigation Report.
   3. PLCM form
   4. Technical Risk Evaluation
   5. Process Optimization Protocols & Reports if any
   6. Process Demonstration Protocols & Reports if any
   7. Process verification Protocols & Reports if any
   8. Technical Risk Assessment if any
   9. PPQ Protocols & Reports
   10. CPV Protocols & Reports
2. Monitoring of Process Optimization/Process demonstration/PPQ batches.
3. Assign batch numbers for Process Optimization batches

Supplier Driven changes (SDC):

1. Preparation of the following technical documents with respect to SDC products:
   • Material Assessment Report for Alternate API/Excipient Source.
   • Master Formula Records
   • Technical Risk Evaluation of SDC products
   • Process Optimization Protocols & Reports if any
   • Process Demonstration Protocols & Reports if any
   • Process verification Protocols & Reports if any
   • Technical Risk Assessment if any
   • PPQ Protocols & Reports if any
   • CPV Protocols & Reports
   • Placebo formulation sheet
     
     
2. Monitoring of Process Optimization/Process demonstration/PPQ/Procss Verification batches.

Documentation:

Preparation of the following documentation requirements for the MS&T activities,

1. Master formula Record.
2. Technical Risk evaluation
3. Process optimization Protocol & Report.
4. Process demonstration Protocol & Report.
5. Technical Investigation report
6. Subject Matter expert analysis report.
7. Technical Summary report.
8. Material Assessment Report.
9. Placebo Formula sheet
10. Technical Summary report
11. Process Performance Qualification (PPQ) Protocol & Report
12. Continued Process Verification (CPV) Protocol & Report
13. Hold time study Protocol & Report
14. Master Manufacturing Record (MMaR) Assessment
15. Other documentation activities Eg: but not limited to
    1. Justification report
    2. Manufacturing Process comparison
    3. Training documentation
    4. Pre-requisite checklists (Part A & Part B)
    5. Revision of Standard Operating procedure, Formats.

• Ensure work complies fully with GMP, SOPs, safety standards, and regulatory requirements.
• Coordinate with Mfg, Pkg, FD, WH, and QA for document approvals, technical issues, and equipment failures.
• To work as a member of a team to achieve all outcomes.
• To perform all work in accordance with all established regulatory and compliance and safety
• Execute other assigned duties based on subject expertise, following directives from the Head of MS&T.

Job Requirements:

• Education
  • Master Degree in Pharmacy or Science.
• Knowledge, Skills and Abilities
  • Essential knowledge: Solid dosage process development and technology transfer for regulated markets.
  • Requires strong understanding of product development, scale-up, and process validation.
  • Needs strong understanding of clinical and regulatory requirements for USA, Canada, Australia, EU.
  • 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 2-5 years of experience in GMP Regulated industry.