Assoc Specialist - MSAT GCC

Job Summary

The Associate Specialist in MSAT GCC will play a crucial role in managing project documentation and meetings, developing solutions through laboratory mockups, and ensuring compliance with validation processes. This position is integral to confirming design requirements and facilitating effective communication among stakeholders, ultimately contributing to the successful implementation of projects.

Responsibilities

• Prepare and manage all meetings and documents related to the project, including agendas, minutes, and team sites.
• Develop solutions by creating mockups in the laboratory.
• Create commissioning protocols to perform testing that confirms design adherence to early requirements.
• Act as a validation expert on System Under Study (SUS) by creating Design Summary Reports (DSR) based on user feedback.
• Conduct Failure Mode and Effect Analysis (FMEA) by organizing workshops with users to capture and evaluate risks associated with validation items and production usage.
• Develop User Requirement Specifications (URS) based on the UR Tool and FMEA findings.
• Create, coordinate, and manage the electronic Change Control (eCC).
• Execute Design Qualification (DQ) based on URS and supplier documentation.
• Develop Validation Master Plans (VMP) to address unmet requirements during DQ.
• Write Installation and Operational Qualification (IOQ) protocols, conduct laboratory tests, and finalize reports based on testing outcomes.
• Compile and summarize validation evidence in Validation Summary Reports (VSR).
• Conduct Chemical Compatibility Risk Assessments (CRA) and Leachable Risk Assessments (LRA).
• Calculate Patient Exposure Scenarios (PES) using raw data from suppliers.
• Conduct risk assessments and write technical rationales.
• Manage the Purchase Order (PO) process and ensure project progress aligns with implementation timelines.
• Anticipate regulatory impacts and documentation needs.
• Ensure full GMP traceability during the shipping of components to external laboratories.

Qualifications

• Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).
• Strong understanding of validation processes and regulatory requirements.
• Proficiency in creating and managing project documentation.
• Experience with laboratory testing and risk assessment methodologies.
• Excellent communication and interpersonal skills for stakeholder management.
• Ability to work collaboratively in a hybrid work environment.
• Strong analytical and problem-solving skills.

Preferred Skills

• Familiarity with Good Manufacturing Practices (GMP).
• Experience in project management and coordination.
• Knowledge of electronic Change Control systems.
• Previous experience in a laboratory setting.

Experience

• Minimum of 3-5 years of relevant experience in validation, project management, or a related field.

Environment

• Hybrid work mode with a combination of in-office and remote work.
• Job location: Bengaluru Luxor North Tower.

Salary

• Estimated salary range: ₹2,500,000.

Growth Opportunities

• Opportunities for career advancement within the organization, including potential leadership roles in project management and validation.

Benefits

• Comprehensive benefits package including health insurance, paid leave, and professional development opportunities.