8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

As a qualified candidate passionate about delivering computer system validation and risk management approaches to support tremendous IT and business growth, you will join the IT team as part of the ITRMC (IT Risk Management & Compliance). In this role, you will interface between the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, the business plans to deploy major operational systems like LIMS, ERP, MES, VLMS, EBR to enhance capabilities and improve customer service, and you will play a crucial role in achieving these objectives. Your responsibilities will include providing technical and compliance expertise for the strategy and execution of computer systems validation in alignment with regulatory standards such as 21 CFR Part 11, 211, 820, GAMP, CSA. You will conduct IT change control impact assessments, develop project documentation, and lead compliance improvement initiatives. Additionally, you will run computer system validation efforts, provide coaching to stakeholders on best practices, advise on IT project execution from a risk and compliance standpoint, and offer IT audit support for internal and external audits. You will stay updated on computer systems validation approaches, industry trends, and health agency guidance, and support software supplier assessments for IT systems within the manufacturing and quality plane. In addition, you will oversee junior roles, staff augmentation, or vendor services for larger projects, ensuring IT life cycle compliance operations are carried out efficiently. The ideal candidate will have a Bachelor's degree in Computer Science, IT, or a related discipline, with 8+ years of experience in pharma/device or other regulated industries. Proficiency in English and citizenship in the U.S. or UK are required. Deep knowledge of lab systems, manufacturing systems, quality systems, and regulatory compliance processes is essential, along with experience in SDLC/GAMP and IT project management methodologies. Additional qualifications such as Lean Six Sigma, ASQ certification, and training in FDA CSA are advantageous.,

Posted 3 weeks ago

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Validation Expert Katalyst Healthcares & Life Sciences

8.0 - 12.0 years

0 Lacs

karnataka

On-site

Looking for a qualified candidate with a passion for delivering computer system validation and risk management approaches to support significant IT and business growth. As a part of the ITRMC (IT Risk Management & Compliance) team, you will work closely with the quality business unit, IT, business customers, and vendors on various computer system validation projects and compliance initiatives. Over the next 3 years, our organization plans to deploy major operational systems like LIMS, ERP, MES, VLMS, and EBR to enhance capabilities and improve customer and patient service. Your role will be crucial in achieving these objectives. Your responsibilities will include providing technical and compliance expertise for executing computer systems validation in compliance with regulatory standards such as 21 CFR Part 11, 211, 820, GAMP, and CSA. You will conduct IT change control impact assessments, develop project documentation, and artifacts, and lead compliance improvement initiatives. Additionally, you will oversee computer system validation efforts, offer guidance on best practices, risk management, and industry trends, and provide support for IT audits by internal and external entities. To be successful in this role, you should have a Bachelor's degree in Computer Science, IT, or a science-related discipline, with at least 8 years of experience in the pharma regulated industry focusing on validation of laboratory, quality, or manufacturing IT systems. Strong knowledge of lab systems, manufacturing systems, quality systems, Document Management Systems, risk management, and audits is required. Familiarity with SDLC/GAMP, Agile cGMP development, and FDA CSA is preferred, along with Lean Six Sigma and/or ASQ certification. If you have operated as a computer systems validation strategy lead, delivered validation packages for IT systems, designed compliance processes, conducted risk management, and worked on data integrity projects in a biopharma or manufacturing environment, you are encouraged to apply. Your expertise in executing computer systems validation within an SDLC framework, collaborating with IT SMEs, and driving cultural change will be highly valued. The ideal candidate must be proficient in English and be a U.S. or UK citizen. If you are ready to take on this challenging yet rewarding role and contribute to our organization's growth and compliance objectives, we look forward to receiving your application.,

Posted 1 month ago

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