- 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.
Qualifications
B.Tech
About Us
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 opportunity
Piramal 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 benefits, 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.
About The Team
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.
