Lead IT Operations and Compliance

Job Description

Job Title: Lead IT Operations and Compliance Qualification: B. Tech(CS)/B.E./BCA/Graduate + Computer Application Diploma with minimum 5+ years of working experience in Pharmaceutical / Life science.Total Experience: 8-12 YearsTechnical Skills

1. Candidate should 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 have good knowledge and work experience on assessing the applications software w.r.t. 21 CFR Part 11 requirements and their remediation.
2. Candidate should have expertise in managing the IT Applications in life science domain in adherence to data security, traceability and integrity.
3. Candidate must have deep knowledge and work experience on GxP QC & Manufacturing Applications Systems Administration, Configuration & Security Policies Implementation, Audit Trail Review Mechanism, Privileges & Roles Management, User Management (User Creation, Modify, Activate, Deactivate, Disable, Enable, Role assignment etc.); and maintaining their compliance as per SOP requirements.
4. Candidate should well versed with GxP Systems data backup & restore strategy w.r.t. pharma regulatory requirements. Must have good knowledge and work experience on data backup, restore and maintaining their compliance as per SOP requirements for GxP instruments/equipment systems such as Chromeleon, Empower, LIMS, KF-Auto Titrator spectrophotometer, LC/MS, HPLCs, GCs, NMR, FT-IR, Ph-Meter, DAS, DCS, PLCs/HMI based SCADAs etc. applications software.
5. Candidate should have knowledge and work experience of implementing the Operating Systems level (Windows) controls on instruments/equipment s connected GxP systems for data protection.
6. Candidate should have good understanding on GAMP and have hands on experience on Computer Systems Validation (CSV) using V-Modal.
7. Preferably candidate should have hands on or application management experience on Empower, Chromeleon, LIMS, ELN, Documentum, Trackwise-QMS and any other scientific application systems.
8. Candidate should have knowledge and working experience of data backup tools preferably Commvault enterprise backup solution.
9. Additional knowledge of ITIL or equivalent process will have weightage.

Roles and Responsibilities:

1. Responsible for monitoring, controlling and providing directions to the team for ensuring smooth IT operations & compliance.
2. Lead the internal and regulatory audits facing team for sites as IT Systems SME. And will able to demonstrate the required compliance & controls are in place w.r.t. IT systems Operations, data security, data traceability and data integrity to the auditors on demand.
3. Responsible for managing the desired optimum data storage space, required infrastructure & capacity planning, backup architecture design & tuning for application systems data backup & restore operations.
4. Responsible for reviewing and ensuring that the data protection controls are implemented, and regular data backup restore are happening as per SOP for Quality Control Labs & Manufacturing systems.
5. Responsible for reviewing and ensuring the regular applications administration activities (System Configuration & Security Policies Implementation, Privileges & Roles Management, User Management etc.) are happening as per SOP for Quality Control Labs & Manufacturing systems.
6. Responsible for Monitoring, Reviewing & Closing the sites IT related Quality Management Records(QMS) records such as - Change Controls, Deviations, Investigation Reports, CAPAs, and audit observations if any.
7. Responsible for ensuring the computer systems qualification and validation (CSV related activities) for GxP systems before usage at sites.
8. Responsible for implementing the required new/revised SOPs at sites and ensuring the overall compliance of the same. And participates in preparation of global IT Policies, Standards and Procedures on need basis.
9. Responsible for identifying the team development and training needs, plan & implement training program for self, team and ensures that training is obtained.
10. Responsible for conducting training for users on the new and existing software solutions and IT SOPs.
11. Guiding the team by contributing knowledge and experience to help them to develop their IT compliance, technical skills, functional knowledge and quality awareness.
12. Responsible for tasks assignment to the team; set specific, measurable, achievable results focused and time bound goals for the team in-line with business IT requirements and complete their performance reviews time to time.

Experience:

• Solid technical background combined with customer service experience
• Industry experience 4-5 years must.

Other Skills

• Ability to work within an interdisciplinary research team.
• Good written and communication skills.

Location: Bangalore,

Keyskills :
it operationsdata securityit compliancedata integritytraining needsquality controluser managementcustomer servicetechnical skillsteam developmentcapacity planning