Junior Manager-IT Operations & Compliance

Job Description

We are looking for a IT Operations SME who can manage and lead the QC & Mfg. Systems at Syngene and provide operational supports for computerized systems.Key Responsibilities: Act as administrators in Operating Systems(OS) and Instrument/Equipment connected application software (including CDS - Empower, Chromeleon, DCS, DAS etc.) in QC/Production areas for Systems Administration, Troubleshooting, and Data Backup/Restore Management. Responsible for identifying the data from instrument/equipment connected application software in QC/Production areas; schedule their backups in backup solution software (i.e. Commvault) and maintain the list as per SOP requirements. Responsible for Performing/Monitoring the data backup as per schedule or manually and maintain the backup media and activities logs as per SOP requirements. Responsible for Performing the data restore on user s requests/periodically, verify it along with users and maintain their activities logs in line to SOP requirements. Able to perform the BMR (Bare Metal Recovery) of systems in case of disaster. Responsible for performing and maintaining the activities logs logging the applications administration activities such as System Configuration & Security Policies Implementation, Privileges & Roles Management, User Management - User Creation, Modification, Enable/Disable, Lock/Unlock etc.) as per SOP for the Quality Control Labs & Manufacturing systems. Responsible for implementing the required security patches at OS level on instruments/equipment s connected GxP computer systems in QC & manufacturing areas. Responsible for verification and correction of date & time on QC instruments and standalone GxP computer systems. Responsible for performing the changes in instruments/equipment connected applications software in QC/Production areas as per change management procedure. Responsible for completing/implementing the sites IT related Change Controls, Deviations, Investigation Reports, CAPAs, and Audit Observations if any. Responsible for execution of computer systems qualification and validation (CSV) activities in QC/Production areas systems as per Computer Systems Validation requirements. Responsible for facing the internal/regulatory audits and will able to demonstrate the required compliance & controls are in place w.r.t. IT systems administrations, Operations, data backup/restore, security, traceability and integrity to the auditors on demand. Responsible for implementing the required new/revised SOPs at sites and ensuring the overall compliance of the same. Liaison with IT Infra team and vendors for technical support/escalations w.r.t. Operating Systems(OS), instrument/equipment connected application software, data backups & restore Responsible for maintaining the updated list of instruments/equipment connected applications software in QC/Production areas as per change management procedure.Educational Qualification: B. Tech(CS)/B.E./BCA/Graduate + Computer Application Diploma with minimum 5+ years of working experience with Pharmaceutical / Life science.Technical/Functional Skills: Candidate must have strong understanding on USFDA 21 CFR Part 11 requirements for electronic record & electronic Signature(ER/ES) specially on data security, integrity and compliance. And should able to assess the application software w.r.t. 21 CFR Part 11 requirements and remediate the gaps if any. Candidate must have knowledge and work experience on data backup, restore and maintaining records as per SOP for GxP instruments connected Quality Control systems such as Chromeleon, Empower LIMS, KF-Auto Titrator spectrophotometer, LC/MS, HPLCs, GCs, NMR, FT-IR, Ph-Meter etc.; and equipment s connected Manufacturing systems such as DAS, DCS, PLCs/HMI based SCADAs etc. Candidate must have working experience on GxP QC & Manufacturing Systems - Administration, Security Policies & Configuration, Privileges & User Roles Management, Audit Trail Review, Date & Time Setting, and User Management (such as User Creation, Modify, Activate, Deactivate, Disable, Enable, Role assignment etc.); and maintaining their records as per SOP. Candidate should have knowledge and working experience of data backup tool preferably Commvault enterprise backup solution. Candidate should have depth technical knowledge of Windows Operating System(OS) administration and troubleshooting. Candidate should have experience of implementing the OS level data protection controls, and OS level patches on instruments/equipment s connected GxP computer systems. Maintaining the inventory lists of instruments/equipment s connected GxP computer systems and applications software for the site.Experience: 5 -8 Years Solid technical background combined with customer service experience Industry experience 5+ years must. Minimum 5-8+ years of experience as Technical IT Operations SME in pharma domain and managing the QC & Mfg. Systems. Good exposure to Quality Management Processes (QMS). Ability & knowledge to perform risk assessment and risk mitigation w.r.t. pharma regulatory requirements on computerized systems. Handling & Managing Internal, External and Regulatory Audits.Behavioral Skills: Excellent written and verbal communication skills. Excellent presentation skills (oral and written) and proven ability to elicit cooperation from senior leaders and other stakeholders Excellent team collaboration skills, ability to lead and motivate cross-functional teams.,

Keyskills :
sapsafetycommissioningmechanicaltroubleshootingequal employment opportunityenvironmental impact assessment