Job Description

Position:
Senior Manager-2
Job Title:
Sr. Manager IT Compliance
Job Grade:
G9B
Function:
CQ IT
Sub-function:
CQ IT Compliance
Manager's Job Title:
DGM
Skip Level Manager's Title:
NA
Function Head Title:
Sr. General Manager
Location:
Vadodara
No. of Direct Reports (if any)
Nil
Areas of Responsibility

• To ensure compliance of all GxP computerized systems as per Sun CS QMS and regulatory requirements.
• Perform GxP computerized systems assessment referring requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security and controls.
• Review of computerized systems of manufacturing systems.
• Emerging and Application of user privileges or access rights for entire Manufacturing and QC computerized systems.
• Overseeing the Manufacturing and Lab IT Compliance Viz., Setting & Verification of Security policies, Periodic Backup & Restoration activity, Investigation of backup failures, Verification windows OS policies and Active users lists for entire of Manufacturing computerized systems.
• Review of OEM and CSV qualification documents for manufacturing systems.
• Conduct Gap Assessment of GxP Computerized systems installed at Manufacturing and Lab area.
• Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps
• Ensure remediation of identified gaps systems compliance in timely manner with the support of team for continuous improvements

• Support sites to comply an internal/ external audit observation.
• Knowledge of Computer Software Assurance (CSA) requirements.
• Perform proactive assessment of regulatory and internal audit observations of one site to others
• Support gaps remediation programs, prioritized the remediation based on risk

• Provide support/guidance to remediate legacy/non-compliant computerized systems, to ensure compliance with applicable regulatory standards
• Support for implementing the global Quality-IT initiatives at sites
• Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle
• Mentor and provide support in the education and training of personnel in relevant areas of compliance and validation for GxP IT systems.

Travel Estimate
Frequent travel required, Approx. 70%
Job Scope
Internal Interactions (within the organization)
With all sites (IT, QA and IT QA)
External Interactions (outside the organization)
Nil
Geographical Scope
Mumbai/Vadodara
Financial Accountability (cost/revenue with exclusive authority)
Job Requirements
Educational Qualification
B. Pharm/M.Sc.
Specific Certification
Nil
Skills
CSV, Review of GxP Manufacturing and QC systems
Experience
12 Years-18 Years
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).