MANISH TARE

Manufacturing IT / QC-IT

• Responsible to follow 21 CFR Part 11 guidelines.
• Ensure all electronic backups should be as per the SOP in both (success/failure)
• Administration of all QC and Mfg. Applications related to instruments.
• Document maintain all records like Team JD’s, SOP, Organogram, PM records etc. and update periodically.
• Make yearly calendar for Periodic Activities like UAM reconciliation, rights review, time synchronization (non-domain).
• Coordinate with quality control and assurance department for document preparation, processes.
• Responsible to manage IT Operations for Guwahati Location.
• Vendor coordination, Negotiation for local purchase.
• Handle escalation, customer complaints and issue unaddressed on time & take it up on priority.
• Periodic access rights review.
• OS hardening enforcement as per the SOP.
• Review, Backup, and restoration.
• Preventive maintenance of Manufacturing GxP systems.
• Ensuring QMS on time.
• Ensuring to attend major breakdown round the clock.

Infrastructure Management

• Responsible to manage complete IT Infrastructure.
• Ensure Data center availability 99.98% all the time as per the agreed SLA.
• Provide access to the storage as on requirements analyze monthly growth for capacity planning.
• Ensure hardware replace out of lifecycle and make provision in the budget accordingly.
• Ensure periodic backup as per the SOP.

Project Handling:

• Prepare a network for standalone equipment’s to manage centrally.
• Roles and privileges harmonization.
• Implementation of E-logbook.

Infrastructure Management

• Responsible to manage complete IT Infrastructure for three plants.
• Coordinate with head office team for new technologies implementations or centralized controlled hardware, software, application etc.
• Handle escalation, customer complaints and issue unaddressed on time & take it up on priority.
• Managing Sapphire ticketing according to IT requirement.

Pharma IT Infrastructure

• Responsible to manage QC applications administration as per the regularity requirement.
• Preparing documents like HLDs/LLDs/Presentation Decks.
• Coordinate with quality control and assurance department for document preparation, processes.
• Prepare & update all USFDA, EMEA, PMDK audit relevance documentation.
• Administrating QC activities for chromatography and non-chromatography applications IT point of view.
• Documentation Preparation -

Standard Operating Procedure (SOP)

Computer System Validation (CSV)

Responsible for Other Management Activities

• Responsible to prepare and control the budget.
• Cost and efforts evaluation for upcoming deals
• Vendor negotiation
• Responsible to manage IT Infrastructure for four GEO locations (3 Plant one Marketing office).
• Vendor coordination, Negotiation for local purchase.
• Ensure daily operations run smoothly.

• Implemented ticketing system based on ITIL process to track, manage & capture day to day issues & problems.
• Implement Bluecoat proxy to control internet uses and track access.
• Implement SonicWALL firewall, enable DMZ and move direct internet facing server to the DM Zone.
• Revoke McAfee antivirus and deploy Symantec with DLP support to stop unauthorized USB access & Data Leakage.
• Migrate two different domains under one forest and started managing from centralized place.
• Deploy WSUS to enforce security patch automatically after approval.
• Prepare SOP for various application for users as well IT department.
• Reducing cost on AMC’s, Licenses, Hardware with hard renegotiation and consolidation of assets.
• Budgeting, Licensing, Tendering, Manage Vendors.
• Prepare and update ISO documents on regular intervals according to the requirement.
• Conduct Internal audit for Software, Hardware & Quality checks.
• Defined R&R for the team, set RACI matrix for complicate huge tasks.

Team Management & Achievements.

• Team of over 15 administrative & technical staff for 3 Geographic locations around the world i.e. India, Italy & US.
• I was responsible for IT Infrastructure Management to smooth functionality.
• Awarded as “Outstanding Leadership at work” for the year 2016.
• Promoted as a Global IT Manager within 1 year of joining.

• Worked across multiple areas of technical support, solutioning, presales also managing a team of 120 members who handling Incident Management, Problem Management, Infrastructure Management, Change Management, Monitoring and end to end service delivery.
• Followed ISO 27001 – Information Security Management System (ISMS) for managing sensitive company information which includes people, processes & IT systems secured.
• Responsible to prepare High level & Low-level diagrams.
• Presentations for new business opportunities, involved to prepare RFP’s for new business.
• Present document to customer after Due Diligence, visit customer please to gather information to prepare documents.
• Leading Infrastructure support team consisting of Windows, Linux, Citrix & DB support within defined SLA.
• Carry out Revenue forecast considering new opportunity and existing business.
• Ensure that service delivery takes place based on the Service level agreements.
• Provide technical consultation to the customers and keep them updated with the current technological advancements.
• Continually seek opportunities to increase customer satisfaction and deepen client relationship.
• Supporting the implementation of corrective actions applying Information Technology Infrastructure Library (ITIL) framework knowledge.
• Project Health controlling & publish the reports.
• Optimization of the cost controlling & identify over cost elements.
• Resource Management & Resource optimization using scaling skill level up, prepare resource multitasking.
• Coordinate with Customer for finance in respect to the delivery.
• Remind customer for payment and save revenue loss.
• Worked under same profile handed additional responsibility e.g.
• Country SPOC in Ghana, SIP lead in Senegal and Due Diligence (New Opportunity) leading for Africa and European countries.

ONSITE ASSIGNMENTS & ACHIEVEMENTS

Ghana:

• Lead for Infra Team (Windows/VM) (2013), SD Lead & Country SPOC (2014).
• Unresolved issues including pending payments with the clients, contractual changes also operational issues like transportation issues, fuel crisis and food were rectified in a timely manner.

Luxembourg:

• Due Diligence for the new Project.
• Head office visit for duel role, Meeting with customer for due diligence and Meeting Senior Management for pending revenue and challenges.
• Management appreciated on email to perform undefined role during the visit.

Senegal:

• Lead for SIP (Service Improvement Plan).
• Got customer appreciation in term of rating 8/10 for entire mission.
• Close all unresolved issue and gap between team and customer.

DRC:

• Due Diligence for the new Project (2015).
• Customer appreciates professionalism approach for due diligence and completed mission before closer date.

Rwanda:

• Transition Lead for Infra.(2012),.
• Pre-Sales, Solutioning, Pre-transition, Transaction, Knowledge Transfer, Shadowing, Reverse Shadowing activity for Infrastructure and Due Diligence.

Italy:

• Internal team Restructuring (2016).
• Meeting with Internal team and restructuring according to management requirement and start the documentation process.

• Maintaining DC, ADC Creation / deletion of user account in Exchange. Rights assign permissions on Folder, Auditing, and changing password in every weekend. Unlock the IDs & Log off the concurrent Login ID.
• Create ERD/systems state every weekend, Daily Backup & Weekly Backup, Monthly Backup, and Yearly Backup. Update Antivirus & checking logs.
• Manage Clustering, WSUS and SCCM server for patches, software deployment and asset management.
• Monitor local network connectivity issues. Take corrective action on any breakdown.
• V-SAT, Lease Line, ISDN line, RF Connectivity. Resolve the connectivity issues related to Switch and VLAN Configuration.

• Answered calls and emails at help desk to assist customers with basic support, bug fixes and configuration issues.
• Explained complex technology-related issues in understandable terms to customers.
• Delivered exceptionally high level of professionalism and support to each customer, upholding company's commitment to service.
• Used remote diagnostic tools to identify sources of certain customer issues.
• Promoted purchase of service contracts and warranties by detailing benefits of each to customers.
• Configured hardware, devices and software to set up work stations for employees.
• Followed up with clients to verify optimal customer satisfaction following support engagement and problem resolution.
• Removed malware, ransomware and other threats from laptops and desktop systems.