SENIOR ASSOCIATE

Department Details

Role Summary

• Ensure documentation aligns with internal SOPs, GMP guidelines, and regulatory expectations • Input document data into the standard registers ensuring that the information is accurate and up to date. • Support document creation, issuance, revision, tracking, and archival in line with the QMS and project timelines. • Qualification & Commissioning Documentation support for URS, DQ, IQ, OQ, and PQ protocols and reports • Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. • Support change control documentation related to qualification and commissioning processes. • Cross Functional Coordination: To coordinate with Engineering, Validation, QA teams to gather required inputs, approvals, and updates for qualification documents. • Provide support during internal and external audits by retrieving and organizing qualification/commissioning documentation. • Collaborate with QA team to ensure timely closure of documentation and audit readiness. • Track documentation workflows to ensure milestones are met and deviations or delays are escalated appropriately. • Ensure data integrity principles (ALCOA+) are maintained throughout all documentation activities. • To attend, record and conduct all trainings required as per training matrix/ schedule. • On routine basis to provide improvement proposal on equipment, process, or quality system. • Daily reporting of activities and updating any issues at work to the superior.

Key Responsibilities

• Ensure documentation aligns with internal SOPs, GMP guidelines, and regulatory expectations • Input document data into the standard registers ensuring that the information is accurate and up to date. • Support document creation, issuance, revision, tracking, and archival in line with the QMS and project timelines. • Qualification & Commissioning Documentation support for URS, DQ, IQ, OQ, and PQ protocols and reports • Support commissioning/ validation activities that include FAT/ SAT/ DQ/ IQ/ OQ and PQ. • Support change control documentation related to qualification and commissioning processes. • Cross Functional Coordination: To coordinate with Engineering, Validation, QA teams to gather required inputs, approvals, and updates for qualification documents. • Provide support during internal and external audits by retrieving and organizing qualification/commissioning documentation. • Collaborate with QA team to ensure timely closure of documentation and audit readiness. • Track documentation workflows to ensure milestones are met and deviations or delays are escalated appropriately. • Ensure data integrity principles (ALCOA+) are maintained throughout all documentation activities. • To attend, record and conduct all trainings required as per training matrix/ schedule. • On routine basis to provide improvement proposal on equipment, process, or quality system. • Daily reporting of activities and updating any issues at work to the superior.

Educational Qualifications

Required Education Qualification: B.Sc
Required Experience: 4 - 6 years