Executive, MS & T-ARPL-NOS AR

Job Summary

• Site technology Transfer:
  • Internal product technology transfers from an Apotex manufacturing site to Apotex research private limited (ARPL), India.
  • Transfer of products from Small Volume Manufacturing Plant to Large Volume Manufacturing Plant and Vice versa within ARPL.
• Technology transfer of  New products:
  • 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 MTS activities.
• All other relevant duties as assigned.

Job Responsibilities

• Site technology Transfer:
  • Review of Technical data package and tooling drawings and Provide support for manufacturing license application.Preparation of technical documents with respect to site transfer such as Form-C,MFR,Technology Transfer Protocol and Report,TRE, Protocols and reports for PO,PD,PPQ,CPV and Hold Study batches,Placebo Formulation sheets,TRA.Monitoring of PO/PD/PPQ batches.Ensure archival of PO/Placebo batch documents to QA and any other activities as assigned.
• Technology transfer of  New products:
  • Preparation of  the technical documents with respect to Technology transfer of new products such as Form-C,MFR,TRE,Protocols and reports for PO,PD,PPQ,CPV and Hold Study batches,Placebo Formulation sheets,TRA.Monitoring of PO/PD/PPQ batches and any other activities  as assigned.
• Manufacturing process support:
  • Troubleshooting of processing issues for commercial batch manufacturing at shop floor.Manufacturng process support in the event of any issues which are unplanned and require immediate resolution.Preparation of TSR, TIR or Subject Matter Expert (SME) Response for an investigation according to QMS Track Wise Investigation procedures.
• Product Life cycle Management (PLCM):
  • Preparation of  the technical documents with respect to PLCM products such as Technical summary report (TSR),Technical Investigation Report (TIR), TRE, Protocols & Reports for PO,PD,Process verification,PPQ and CPV batches,TRA.Monitoring of PO/PD/PPQ batches.
• Supplier Driven changes (SDC):
  • Preparation of  the technical documents with respect to SDC products such as MAR,MFR,TRE,Protocol & Report forPO,PD,Process verification,PPQ & CPV batches,TRA, Placebo formulation sheet. Monitoring of PO/PD/PPQ/Procss Verification batches.
• Documentation:
  • Preparation of the following documentation requirements for the MTS activities such as Product code Allocation, MFR,Technology transfer Protocol and Report for Manufacturing & Packaging, TRE, Protocol & reports for PO, PD,PPQ, CPV and hold time study batches,Technical Investigation report,SME analysis report,Technical Summary report,MAR, Placebo Formula sheet, Technical Summary report, Master Manufacturing Record (MMaR) Assessment, Other documentation activities Eg: but not limited to Justification report,Manufacturing Process comparison,Training documentation,Pre-requisite checklists (Part A & Part B),Revision of Standard Operating procedure, Formats.
  • Ensure work is performed in full compliance with good manufacturing practices, standard operating procedures, established safety standards, and regulatory requirements. Coordinate with various departments such as Mfg, Pkg, FD, WH, QA Validation related to document review and approvals,technical processing issues and equipment failures.To perform all work in accordance with all established regulatory and compliance and safety   requirements.

Job Requirements

• Education
  • Master Degree in Pharmacy or Science.
• Experience:
  • 2 year-4 years
• 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.
  • Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
  • The willingness to upgrade knowledge/education on an on-going basis.