- To manage all aspects of the Technology transfer of new product and existing site transfer projects and testing of a wide range of products to third party suppliers.
- Manage all CMC regulatory affairs and regulatory submissions activities resulting from changes to the Marketing Authorisations arising as a result of the site transfer till commercialization.
- Managing any other work areas as identified by the Managing Director/Head of Department for the benefit of the organization.
- Review of dossier data, GAP analysis across dossier data and current anticipated changes.
- Setting the project milestone and to review project status with departmental head on weekly basis to ensure the timely delivery of projects.
- Technical assessment and execution of new project transfer.
- Comply with the committed time-lines for technology/site transfer activities assigned per year.
- Co-ordination and continued follow up with CMOs to get interest on priorities.
- Co-ordinate with Regulatory team and the CMO for the Artworks development and Printer proofs finalization.
- Support for preparation of Artworks required for Regulatory Variations.
- Support for Artwork approval form and Printer proof approvals.
- Planning, execution and evaluation of Engineering Batch manufacturing.
- Evaluation of analytical methods workability, AMT, verification & validation strategy and evaluation for analytical methods.
- Review of manufacturing batch documents prior to validation and subsequent process viz. BMR, BPR, Spec, MOA, Process validation, Hold time & stability protocol, AMT & AMV protocols.
- Initiation, approval, closure of document and technical change control within the proposed time-lines.
- Initiation, investigation, report writing and closure of NCR and CAPAs within the time-lines.
- Drafting, review and approval of risk Assessments, technical Reports if any.
- Liaise with QA during ISO audits and GDP/GMP audits.
- Timely drafting and approval of ePMF, arranging the required documents for QP/PRRC initial batch release.
- Arranging the samples for UK testing and evaluating the results of UK Lab COA v/s CMO QC Lab results Stock Management.
- Support to medical device regulatory team for preparation of registered medicinal product details document.
- Liaise closely with logistics coordinator for the supply chain of validation batches.
- To meet the project deadlines as agreed with the management and liaise with CMO accordingly
- Creation of POs in Navision for all relevant departmental activities.
Qualifications and Experience (as applicable):
- Bachelor’s/ Master’s degree in Chemical Engineering / Pharmacy/ Chemistry.
- A minimum of five year's work experience in the pharmaceutical industry in R&D/Manufacturing/analytical testing/CMC department with expertise of Technology transfer.
- Current working knowledge of development pharmaceutics, Technology transfer, pharmaceutical analysis, and regulatory affairs of pharmaceutical products.
- Hands on project management and People management experience.
- Able to perform risk analysis, troubleshooting task and knowledge of quality regulation such as cGMP.
- Excellent interpersonal skills and Excellent attention to detail. Setting the project milestone and to review project status with departmental head on weekly basis to ensure the timely delivery of projects.
Medical Device | OSD | Oral Solid Dosage | Tablets | Capsules | Tech Transfer | GMP | Manufacturing | Regulatory | Pharma | Pharmaceutical | Project Management | Good Manufacturing Practice | Technology Transfer