Validation Lead

Major accountabilities:

Stewardship

• Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle
• Create and maintain a product specific Quality Risk Analysis (QRAs).
• Ensure creation of Master Batch Record.
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
• Ensure inspection readiness for all process related aspects of assigned products.
• Track and evaluate product performance, trending, detect issues, implementation of CAPAs.
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
• Present product performance and status of product improvement projects in site Manufacturing Robustness Review Board (MRRB).

Validation

• Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
• Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV), ongoing cleaning verification.
• Ensure that all manufacturing and cleaning processes are validated, overview on state of validation at site is maintained.
• Establish and monitor validation KPIs.
• Maintain all validation activities in an inspection ready status. Product is maintained in constant state of validation.
• Author complex validation protocols.
• Establish local procedures & templates for respective validation documentation.
• Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
• Provide technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. 
• Be a senior advisor in case of difficult validation challenges at Site.
• Host validation council.
• Support Site MS&T Head in ensuring that responsible departments execute and maintain the VMP activities.
• Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment qualification / utilities qualification, system qualification, analytical method validation.
• Ensure that the ongoing verification report (OPV) is established on time in alignment with the APQR.
• Ensure inspection readiness for all process related aspects of assigned products.

Performance Qualification

• Prepare Qualification documents of equipment with leverage to Global standard Qualification approach/practice.
• Engage cross functions including 3rd party to ensure that all PQ activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated
• Ensure PQ activities and Documents along within project schedule and budget.
• Facilitate execution of integrated line PQ, provide insight to finalize process design.

Launch & Transfer

• Participate in transfers and launches, Provide technical expertise for pre-validation / validation strategy.
• Create documents requirement in MPT
• Contribute to providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.

Manufacturing Excellence

• Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.

Training

• Own the Training Curriculum for own Profile and direct reports.

Novartis Manufacturing Manual

• Support implementation of Novartis Manufacturing Manual principle 3.
• Represent site in validation network.

Key performance indicators:

• Validation Master Plan (VMP) completed and up to date.
• Product maintained in a constant state of validation.
• Transfers/launches implemented on schedule and on target without validation related issues. Deliver validation data that meet the target schedule and quality to support the required registration documentation.
• Validation approach meets Novartis QM requirements, health authority and industry standards.
• OoS, OoE, Deviation, CAPA, compliant, recall – process-related.
• Completeness of Regulatory CMC dossier.
• All related SOPs are updated on time.
• Success rate of Health Authorities’ inspections.

Minimum Requirements:
Work Experience:

• 8-year experience in manufacturing / manufacturing science and technology / technical development / quality of aseptic process.
• Thorough understanding of manufacturing processes and related process equipment.
• Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• 5-year experience in executing process validation, having led and managed validation projects,  process support, e.g.  Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC. 
• Expert in reviewing and writing technical reports.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
• Fundamental understanding of standard pharmaceutical analytical testing.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Sound experience of data handling and applied statistics is a must.

Skills:

• Knowledge Of Gmp.
• Manufacturing Process & Technologies.
• Process Validation & Process Control.
• Control Strategy and Process Performance Monitoring
• Risk Management.
• Applied Statistics.
• General HSE Knowledge  .

Languages :

•  Fluent in English and proficient in country language.