Manager QA(CSV)

5 days ago

Mumbai, Maharashtra, India Qinecsa Solutions Full time US$ 90,000 - US$ 1,20,000 per year

We are in the process of strengthening the Quality team within the Technology business unit and are seeking a highly skilled and motivated IT Quality Sr Manager who will play a critical role in ensuring the quality and compliance of our IT systems. This role provides the right candidate an opportunity to make a real difference in overseeing and improving the quality processes, ensuring continuous improvement, managing the internal and external audit programme, and improving the QMS.

Key Responsibilities:

Manage a team of Quality specialists and CSV experts. Build and lead a team of validation and IT Quality professionals, providing guidance, training, and support. Ensure that quality management policies and procedures adhere to industry standards and governing regulations. Maintain the CAPA management process working with different stakeholders to ensure their timely closure. Monitor key performance indicators (KPIs) for quality assurance. Assist in carrying out the internal audits to assure adherence to the QMS. Carry out supplier audits as part of the audit supplier audit schedule. Carry out and manage periodic reviews of IT systems and applications. Ensure regulatory compliance of GxP systems by the application industry standard regulations, such as FDA 21 CFR Part 11 and GAMP 5, and ensure that computer systems align with these standards. Provide Company wide training in the areas of CSV and IT Quality.

Qualifications & Experience

You should have a strong industry background in Computer Systems Validation and IT Quality gained within the life science industries with an excellent regulatory knowledge. We would expect you to have knowledge and understanding of providing SaaS and have had client facing experience. Degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences), with a Master's degree preferred and 10 years of experience in computer systems validation and/or IT Quality. Strong knowledge of regulatory requirements and industry guidance in the areas of GvP, FDA 21 CFR Part 11, GAMP 5 and a strong knowledge of Data Integrity requirements. Knowledge of infrastructure qualification. Excellent leadership and team management skills. Strong communication and interpersonal abilities to work effectively with cross-functional teams. Attention to detail and a strong commitment to quality assurance and compliance.

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