To actively participation during successful technology transfer of products from R&D to various manufacturing locations
To verify the technology transfer documents issued from F&D/ADL for adequacy and accuracy.
Responsible for scale-up and identification of critical process parameters in consultation with F&D
Prepare and review scale up reports based on the optimization batches clearly identifying the critical process parameters and defining the limits for the same to form a basis for F&D to issue DMBD
To keep track of requirements and ensure timely procurement of the same.
To take guidance related to tech transfer project and lab related work.
To guide the Officer to resolve any problem obtains during the Tech transfer.
To review on-line documentation of protocols, reports, testing during scale up and exhibit batches manufacturing.
Prepare and review of process validation protocols and reports meeting all the filing requirements
Execution of exhibit batches for filing and co-ordinating with QA for process validation sampling
Co-ordination with QA for providing stability samples to exhibit stability cell
Execute and ensure for covering all the aspects of Quality by Design (QbD) in terms of finalizing a scalable manufacturing process.
Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production runs.
To escalate any odd observations during scale up and exhibit batches.
Investigate any OOS / Deviation /OOT during scale up and Exhibit batches.
Ensure accurate and complete documentation as per GDP requirements and maintain Good Manufacturing Practices (cGMP) requirements.
To interact with the plant team and impart new product introduction training before production.
To co-ordinate with the Cross functional members like F&D, sourcing, analytical Development, quality assurance, quality control, IRA to ensure that projects are planned and executed in a timely manner.
To check the technical feasibility for manufacturing new product proposed by NPD in existing manufacturing set-up.
Participate in investigations of product failure including quality, potency, visual characteristics etc. Ensure involvement in all trouble-shooting activities.
To help IRA in getting the required documents from plant for filing and for responding the regulatory agency queries.
To handle USFDA/MHRA and other regulatory audits with respect to Manufacturing Process and Process Validation
3 - 7 years of experience in Technology Transfer/ F&D/ R&D department in Pharmaceutical industry, preferably in injectable products
Thorough understanding scale up and technology transfer of Injectables
Knowledge of Process validation
Experience of manufacturing process and shop floor.
Knowledge of ICH Guideline
Trouble shooting of various problems obtain during the product development
Knowledge of Transfer of Technology
Knowledge of Good Laboratory Practice and Good Documentation Practices
Knowledge of Quality by Design.
Educational Qualifications : B. Pharma / M. Pharma
Personal Attributes and skills : The candidate should have
Good communication and interpersonal skills,
Ability to manage multiple responsibilities
Attention to details and team player
Claris Lifesciences is an Indian sterile injectables pharmaceutical company with a... market presence across 100 countries worldwide. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses. Read full description