Sun Pharmaceutical Industries Ltd Looking for Manager Quality (CQ IT) at Dewas, Madhya Pradesh

Sun Pharmaceutical Industries Ltd; Dewas; On-site; INR 6,75,000 - 9,00,000; Full time

Job summary

An established industry player is seeking a Manager for CQ IT to ensure compliance of GxP computerized systems and support audit readiness. This role involves coordinating with teams to address compliance gaps, conducting audits, and implementing quality procedures. The ideal candidate will have a strong background in regulatory standards and a commitment to maintaining high-quality standards throughout the lifecycle of computerized systems. Join a forward-thinking company where your expertise will contribute to impactful quality initiatives and drive excellence in IT compliance.

Qualifications

• 12-15 years of experience in regulatory plant/company preferred.
• Strong understanding of GxP computerized systems and regulatory compliance.

Responsibilities

• Ensure compliance of GxP computerized systems as per regulatory requirements.
• Support sites for audit readiness and conduct periodic validation reviews.

Skills

GxP Compliance

Regulatory Standards

Audit Readiness

Computerized Systems Validation

Quality Management Systems

Education

B. Pharma

M. Pharma

Tools

Quality Management Software

Validation Tools

Job description

Designation: Manager (CQ IT)

Qualification: B. Pharma/M. Pharma

Experience: 12 to 15 Years

Candidate from Regulatory plant/Company having similar experience will be preferred.

Job Responsibilities:

1. Ensure compliance of all GxP computerized systems as per Sun CS QMS and regulatory requirements.
2. Perform GxP computerized systems assessment referring to the requirement of 21 CFR part 11, EU Annex 11, applicable regulatory standards, adequate security, and controls.
3. Timely communicate/discuss identified gaps to the responsible team. Coordinate with the relevant team for compliance/closure of the identified gaps.
4. Support sites for audit readiness with respect to CS validation, operational management, and compliance with internal/external audit observations.
5. Perform proactive assessment of regulatory and internal audit observations from one site to others.
6. Conduct periodic validation status reviews of computerized systems with the support of relevant stakeholders.
7. Prepare and implement relevant quality procedures for computerized systems (SOPs).
8. Ensure alignment of site SOPs related to ‘Computerized Systems’ against global CSQMS.
9. Support and effectiveness check of GQS/GSOPs implementation at sites.
10. Provide support/guidance to remediate legacy/non-compliant computerized systems to ensure compliance with applicable regulatory standards.
11. Support the implementation of global Quality-IT initiatives at sites.
12. Ensure availability of inventory of IT systems, infrastructure, CSVMP, and its compliance with CSQMS.
13. Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle.
14. Monitor and approve QMS related to software and hardware for application systems and IT infrastructure in line with the organizational/site-specific procedure.
15. Provide support for conducting audits of suppliers and vendors who impact the development, implementation, and maintenance of computerized systems.
16. Perform on-site audits of vendors whenever a new vendor is introduced in the organization or for periodic qualification of vendors to assure their Quality Systems are effective and meet standards.