Nazreen

❖Implementation of the CaliberLIMS (Laboratory Information Management System) application (version: 3.9.0.E) as per the regulatory requirements for the Quality control department across the Granules India Limited sites i.e. Gagillapur, Jeedimetla, Bonthapally, Vizag (Unit-IV & Unit-V).
❖Review and approvals of the User requirement specification (URS), Initial Risk assessment (IRA), Validation plan, Functional specifications (FS).
❖Review and approvals of the Standard Operating procedures (SOPs) and providing the training on the implemented modules to the concerned departments.
❖Review and approvals of the Qualification protocols (IQ, OQ, PQ) and execution of the qualifications.
❖Review and approvals of the validation summary reports and Traceability matrix.
❖Gap Assessment-As per the regulatory guidelines, verification of the facility for the compliance and bridging the gaps in the system.
❖Involving in the computer system validation, QMS activities. Change Control, Deviation, CAPA, QRM, Mitigation plan, GAMP 5, 21 CFR Compliance.
❖Verification and evaluation of security management Electronic records and Electronic signatures deliverables as per 21 CFR Part 11 regulatory requirements.
❖Verification, evaluation and approval of the System Retirement/System decommissioning activities.
❖ Responsible for the indenting the requirements and clearing of payment to service providers.
❖ Review of Impact Assessment, change controls, CAPA and deviations as per system policy.
❖ Responsible for the Backup restoration of data pertaining to electronic application software’s (LIMS, QAMS, DMS & Nichelon etc., applications) as per the defined procedures and schedule timelines.
❖Responsible for the periodic audit review of electronic applications software’s (LIMS, QAMS, DMS & Nichelon etc., applications) as per the defined procedures and schedule timelines.
❖Responsible for the initiation of tickets for the electronic applications with the vendor as per the department user concern and ensure the closure with in the timelines with appropriate documentation.
❖Responsible for the internal audits and also ensure the same is implemented follow-up and tracking for the QMS elements initiated by cross functional teams.
❖Responsible for Harmonization of SOPs and providing the training to the across the Granules India Limited (i.e. Gagillapur, Jeedimetla, Bonthapally, Vizag (Unit-IV & Unit-V)).
❖Conducting the Contract testing laboratories audits as per the schedule.
❖Responsible for the trainings to SBT (Swarna Bharathi Trust) trainees for the Quality control department job role and responsibilities.
❖Responsible for the review of the Quality elements trend (Incidents, OOS, OOT & deviations).
❖Responsible for review and approval of the Qualifications (IQ, OQ & PQ) of Instruments & Equipment’s.
❖Responsible for the delivering the projects (new applications) with in the committed timelines (as per the project road maps).
❖Responsible for the smooth functioning of the projects by conducting the project meeting with the CFTs.
❖Worked as a stability section team lead with the number of reportees 15 and responsible for the execution of the stability samples testing within the stipulated time period.
❖Handling of the qualification activities related to the Empower software (for HPLC & GC).
❖Responsible for the verification of the Audit trails in the Empower software (FR 5) & standalone instruments.
❖Responsible for handling of Incidents, OOS, OOT & deviations and change controls and taking the actions to complete in a timely manner.
❖Responsible for the reduction of quality management elements (Incidents, OOS, OOT & Deviations).
❖Responsible for the review of trends of the Incidents, OOS, OOT & deviations in the Quality control laboratory.
❖Responsible for providing the audit response of internal and external audits from quality control department.
❖Responsible for the review of the stability compilation sheets.
❖Responsible for the review of the Quality control SOPs/ STPs.
❖Responsible for the Annual calibrations of the Quality control instruments and equipment’s.