Deputy Manager, Manufacturing Science and 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:
  1. 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.

Job Responsibilities

• Site technology Transfer:

1. Review of Technical data package for site transfer products.
2. Review of tooling drawings of site transfer products.
3. Provide support for manufacturing license application of site transfer products.
4. Prepare and review cleaning validation documents;.
5. Cleaning validation related activiteds and e-Residue software application activities.
6. Prepare and review PDE changes.
7. Prepare and review of quarterly and annual monitoring reports for cleaning validation.
8. Preparation/review following technical ldocuments with respect to site transfer:

• Site transfer strategy Report
• Cross contamination quality risk assessment report for New product introduction at ARPL.
• Master Formula Records
• Technology Transfer Protocol and Report for manufacturing and packaging
• Technical Risk Evaluation of Products transferred from Apotex manufacturing sites to ARPL India
• Process Optimization Protocols & Reports
• Placebo Formulation sheets
• Technical Risk Assessment
• PPQ & CPV Protocols & Reports
• Annual Product Quality Review.

1. Change control Assessment for the following:

• New product introduction of site transfer products at ARPL.
• Master Manufacturing Records
• Specifications (Inprocess SFG FP) and PV test profiles

1. Assign batch number for Process Optimization batches and Placebo batches
2. Ensure archival of Process Optimization/Placebo batch documents to QA.
3. Training on technical aspects to CFT as applicable
4. Monitoring of Process Optimization/Process demonstration/PPQ batches.
5. Any other activities as assigned related to site technology transfer.
   
   

Technology transfer of New products:

1. Change control Assessment for the following:

• New product introduction at ARPL.
• Master Manufacturing Records.
• Specifications (Inprocess SFG FP) and PV test profiles.

1. Preparation/review of the following technical documents with respect to technology transfer of new products:

1)Cross contamination quality risk assessment report for New product introduction at ARPL.

2) Master Formula Records

3) Technical Risk Evaluation of new products

4) Process Demonstration/Optimization Protocols & Reports

5) Hold Study Protocols & Reports If any

6) Placebo Formulation sheets

7)Technical Risk Assessment

8) PPQ Protocols & Reports

9) Nitrosamine Risk Assessment Report

10) CPV Protocols & Reports

1. Assign/review of Protocol and Report Numbers for Process Optimization batches and Placebo batches
2. Training on technical aspects to CFT as applicable.
3. Monitoring of Process Optimization/Process demonstration/PPQ batches.
4. Any other activities as assigned related to New product launch.
   1. Manufacturing process support:
   2. Troubleshoot and support unplanned manufacturing issues on the floor immediately.
   3. Write technical investigation reports (QMS).
   4. Product Life cycle Management (PLCM):

• Preparation/review of the following technical ldocuments with respect to PLCM products:
  1. Technical summary report (TSR)
     1. Technical Investigation Report (TIR).
     2. PLCM form
     3. Technical Risk Evaluation
     4. Process Optimization Protocols & Reports if any
     5. Process Demonstration Protocols & Reports if any
     6. Process verification Protocols & Reports if any

Job Requirements

• Supplier Driven changes (SDC):

1. Change control Assessment for the following:

• Supplier driven change.
• Specifications (Inprocess SFG FP) and PV test profiles

1. Preparation/review of the following technical ldocuments 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
• Annual Product Quality Review
• Placebo formulation sheet

1. Assign batch numbers for Process Optimization batches and Palcebo batches

• Documentation:

Prepare/review the following documentation requirements for the MS&T activities

1. Product code Allocation
2. Allotment of batch number for Optimization and placebo trials batches
3. Master formula Record.
4. Technology transfer Protocol and Report for Manufacturing & Packaging
5. Technical Risk evaluation
6. Process optimization Protocol & Report.
7. Process demonstration Protocol & Report.
8. Technical Investigation report
9. Subject Matter expert analysis report.
10. Technical Summary report.
11. Material Assessment Report.
12. Placebo Formula sheet
13. Technical Summary report
14. Process Performance Qualification (PPQ) Protocol & Report
15. Continued Process Verification (CPV) Protocol & Report
16. Hold time study Protocol & Report
17. Master Manufacturing Record (MMaR) Assessment
18. Change control Assessments
19. 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.

• Coordinate with the GTA team to make sure the technology transfer to ARPL is timely robust and results in a validation-ready product.
• Ensure work complies with GMP SOPs safety and regulations; manage employees safely.
• Liaises with various departments such as Mfg Pkg FD WH QA Validation regarding pertinent issues related to materials batch records technical processing 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 requirements.
  
  
  

• Education
  • Master Degree in Pharmacy
• Experience
  • Minimum 11 years of experience in Technology Transfer of the Pharmaceutical product / Formulation development for regulated market

Knowledge Skills and Abilities:

• Should have knowledge of process development 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 understanding of clinical and regulatory requirements of USA Canada Australia and European regulatory agencies.
• Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.