Executive or Sr. Executive or Assistant Manager R&D

Role & responsibilities

RESPONSIBILITIES

• Product is maintained in constant state of validation
• Product history is documented and available and current since transfer from development to date
• Continuously improving CpK (process capability)/ Ppk (Process Performance)
• Degree of standardization of product process.
• Genotoxic and elemental impuirty assessment in all APIS
• Nitrosamine impuirty assessment
• Transport risk assessment
• Investigation and data analysis of Customer Complaints, Recalls, Recurring Deviations and OoS, OoE Out of Specification, Out of Expectation.
• Success rate of Health Authorities inspections.
• Completeness of Reg CMC dossier
• Effective CAPA.
• Continuously improving Yield.
• Technical reports executed on time and with the right expectations.

Preferred candidate profile

Transfer OUT process

• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.

Investigations/improvement on product

• Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams
• Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritised and monitored
• Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters

Validation:

• Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples
• Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications / Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts
• Approves both Validation Protocols and Report

Testing Monograph oversight:

• Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content

Change control:

• Ensure oversight of technical changes and lead end- to- end change control management related to technical issues, working cross- functionally as required.

Training:

• Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position

Regulatory Filings:

• Act as the interface for the site with the relevant Health Authorities for technical issues.

• Review and releases regulatory proposals or information required for regulatory filings.
• Genotoxic impuirty assessment, Nitrosamine impuirty assessment, Elemental impuirty assessment and Transport risk assessment report.

Audit support:

• Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit

Key process safety related roles and responsibilities

• Responsible for the safe operation of one or more processes and the appropriate training of the operators in the process. Facilitate team which carries out ZHA before introducing the process.
• Prepare overall plan for Integrated Management System documentation, control and its implementation within the department in close coordination with respective HOD’s including implementation of Olon Health, Safety & Environment system as per CHSE guidelines.
• As appropriate, responsible for implementation of, compliance to and governance of practices specifically prescribed to this role by the Novartis Manufacturing Manual.

Perks and benefits