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

Qualification- B. Pharma/.M.Pharma

Exp- 12 to 15 Years of Exp

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

Job Responsibilities:
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

Timely communicate/discuss identified gaps to responsible team. Coordinate with relevant team for compliance/closure of the identified gaps

Support sites for audit readiness with respect to CS validation, operational management and to comply an internal/ external audit observations

Perform proactive assessment of regulatory and internal audit observations of one site to others

Perform periodic validation status review of computerized systems with the support of relevant stakeholders

Preparation and implementation of relevant quality procedures for computerized systems (SOPs).

Ensure alignment of sites SOPs related to ‘Computerized System’s against global CSQMS

Support and effectiveness check of GQS/GSOPs implementation at sites

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 availability of inventory of IT systems, infrastructure, CSVMP and its compliance with CSQMS

Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle

Monitor and approval of QMS related to Software and hardware for application systems and IT infrastructure in line with the organizational/site specific procedure

Provide support for conducting audit of suppliers and vendors who impact development, implementation and maintenance of computerized systems

Perform on site audits of vendors whenever new Vendor is introduced in organization/periodic qualification of vendor to assure vendor’s Quality Systems are effective and meet standards