Key Responsibilities:
Ø Responsible for handling Instrumentation equipment breakdown in process, packing and all other areas.
Ø Responsible for planning and execution of Preventive Maintenance Program (PMP) in SAP for all process equipment.
Ø All laid down procedures and safety standards to be followed.
Ø Responsible for implementation of spares management for Process and utility systems.
Ø Responsible for cross functional coordination as required completing the Instrumentation system implementation.
Ø Qualifying & Co-ordination with internal and external vendors for routine maintenance issues, operation contracts and for in-house Engineering projects as per current SOP.
Ø Preparation & review of SOP's and revisions of the same.
Ø Explore the possibility to improve / modify existing systems, equipment for better compliance to cGMP and GDP.
Ø Hands-on experience in handling VFDs, PLC, HMI, SCADA and other process instruments.
Ø Responsible for Instrumentation of In-house projects planning and execution.
Ø Coordinating with all CFT's for equipment qualification & validation activities.
Ø Responsible for User ID's, Password creation/deletion and Software/data Backup's of all Process Equipments wherever applicable as per current SOP.
Ø Identify the root cause and implement appropriate corrective and preventive actions.
Ø Executing of SAP projects of Plant Maintenance at Site level coordinating with Central Engineering and IT Department.
Ø Innovative ideas and Suggestion shall be provide to team for the department growth and actively executing the define tasks.
Ø Having exposure in Facing FDA and other Regulatory audits.
Ø Good trouble shooting and problem resolving skills for OSD, Compression, Tube filling and Soft gelatin manufacturing process equipment.
JOB DESCRIPTION FOR QA.Specific Qualification M.Sc/M.Pharm/B.Sc/B.Pharm.
Responsible for Implementation, continuous monitoring and reviewing of Quality management system and obtaining of updated regulatory information and implementation in laboratory.
Responsible for reporting of deviations to management and conducting of management review meetings.
Responsible for conducting of internal audits, handling of customer complaints, investigation and Quality checks.
Responsible for approving of new Quality system procedures and revision of existing procedures as per regulatory requirements, for issuance of Deviation, OOS, OOT, CAPA, & Change control forms and follow up with respective departments.
Non conformity activities timely reporting to customer, Conducting of training on latest regulatory requirements.(SOP training, On job-training & class room training)
Responsible for work allocation & monitoring of regular activities, assuring of analytical results and releasing of COAs for routine samples and stability samples.
Responsible for approving of Validation master plan and Qualification protocols for equipments in the laboratory, reviewing and approving of method transfer protocols and reports and work record
Responsible for approving of analytical method development and method validation protocols and reports, review and approval of all records and protocols pertaining to stability study management.
Overall implementation and monitoring for effectiveness of stability procedure, activation of stability study in LIMS and approving of stability reconciliation.
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