Ensuring that computer system validation deliverables like GXP Software categorization software qualifications configuration specification Risk assessment negative challenging tests backup restore procedure validation summary report requirement traceability matrix and 21 CFR part 11 requirements are available for all the GxP systems To revisit the site specific SOP s related to IT and ITC periodically to in line with the corporate IT guidelines current regulatory standards and to maintain the work practices is in line with the current SOP s Preparation and Execution of the IT Roadmap for the site Facing Regulatory and customer audits and presenting the IT compliance status with the support from the respective SME Evaluating reviewing the IT observations internally or during the audits and supporting the respective department in identifying effective CAPA To perform IT supplier assessment for GAMP3 GAMP4 or GAMP5 software before procuring Perform adequate investigation and providing the root cause for the deviations identified during the failures Deviations of computerized systems To ensure that all the computerized systems are meeting the 21 CFR part 11 and electronic signatures records requirements To review and approve of all the validation qualification documents related to computerized systems and ensuring the documents are in compliance To ensure that all IT related Risk assessments are made and necessary Risk mitigations are executed Providing the sufficient training to the site team and ensuring that all the IT team members are become experts in their job role Report any incident accident near miss illness to the superiors Identify unsafe conditions and unsafe acts and report to superiors In the three decades of its existence Piramal Group has pursued a twin strategy of both organic and inorganic growth Driven by its core values Piramal Group steadfastly pursues inclusive growth while adhering to ethical and values-driven practices Equal employment opportunityPiramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer We do not discriminate based upon race ethnicity religion color national origin gender including pregnancy childbirth or related medical conditions sexual orientation gender identity gender expression age status as a protected veteran status as an individual with a disability genetics or other applicable legally protected characteristics We base our employment decisions on merit considering qualifications skills performance and achievements We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters including recruitment selection training placement promotion demotion compensation and advantages transfers terminations and working conditions including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice Piramal Pharma Solutions PPS is a Contract Development and Manufacturing Organization CDMO offering end-to-end development and manufacturing solutions across the drug life cycle We serve our customers through a globally integrated network of facilities in North America Europe and Asia This enables us to offer a comprehensive range of services including drug discovery solutions process pharmaceutical development services clinical trial supplies commercial supply of APIs and finished dosage forms We also offer specialized services such as the development and manufacture of highly potent APIs antibody-drug conjugations sterile fill finish peptide products services and potent solid oral drug products PPS also offers development and manufacturing services for biologics including vaccines gene therapies and monoclonal antibodies made possible through Piramal Pharma Limited s investment in Yapan Bio Private Limited Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide