Product Steward

Job Description Summary

-Validation ExpertExecuting and managing process, primary packaging, and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations.Scientist MSAndTDesign, plan, perform, interpret and report scientific experiments under the lead of the department head to contribute to overall MSAndT strategies and objectives.  

 

Job Description

Major accountabilities:

• Validation Expert -Support Product Steward in maintaining the process control strategy.
• Translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
• Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV).
• Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation readyScientist MSAndT -Comply with applicable GxP regulations, SOPs, HSE, ISEC And other Novartis Guidelines in the laboratory and, -Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving.
• Contribute to and maintain lab instructions, SOPs, templates.
• Support, qualification and calibration of lab / pilot equipment with accompanying documentation, schedule and perform routine maintenance.
• Contribute to the evaluation of new equipment.
• Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation.
• Prepare and review appropriate GxP documentation including change requests.
• Participate in Tech Transfer activities from laboratory to industrial scale, support validation activities.
• Identify improvement options of current processes, propose business cases.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Meet established validation milestones according to approved validation plans.
• Audit and inspection outcomes as a measure of validation compliance with global regulatory expectations.
• Timing and quality of technical reports.
• Timely and successful implementation of transfer activities (e.g. lab-to-lab transfer in launches).
•   

Minimum Requirements:
Work Experience:

• Fix-its/Turnarounds.
• Project Management.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills:

• Assembly Language.
• Change Control.
• Chemical Engineering.
• Chemistry.
• Continual Improvement Process.
• Cost Reduction.
• Data Analytics.
• Electronic Components.
• General Hse Knowledge  .
• Including Gdp.
• Knowledge Of Capa.
• Knowledge Of Gmp.
• Lean Manufacturing.
• Manufacturing (Production).
• Manufacturing Process.
• Pharmaceutics.
• Process and Cleaning Validation.
• Process Control.
• Process Engineering.
• Risk Management.
• Root Cause Analysis (Rca).
• Scheduler.
• Six Sigma.
• Sop (Standard Operating Procedure).

Languages :

• English.

 

Skills Desired

Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge  , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Pharmaceutics, Process and Cleaning Validation, Process Control, Process Engineering, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure)