Info Tech _Team Member - IT Quality and Compliance

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolioof biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, severalwith Sandoz and is developing many independently. BioconBiologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

Job Level: Associate Manager - IT quality and Compliance

Location: Bengaluru (Jigani Link Road)

Job Type: Full-Time

Experience Required: 5-6 years in Life Sciences with 3-4 years in IT

Job Description:

Ideal candidate will have a strong background in the life sciences domain, with hands-on experience in the validation of scientific applications such as Laboratory Information Management Systems (LIMS) and other laboratory instruments

Key Responsibilities:

• Lead and manage the validation processes for scientific applications, ensuring compliance with industry standards and regulations.
• Collaborate with cross-functional teams to implement and maintain LIMS and other scientific applications.
• Provide technical expertise and support for the integration and optimization of scientific applications.
• Develop and execute validation protocols, test plans, and reports.
• Ensure data integrity and security within scientific applications.
• Troubleshoot and resolve issues related to scientific applications and their interfaces.
• Stay updated with the latest trends and advancements in life sciences and IT.

Qualifications:

• Bachelor’s or master’s degree in Life Sciences, Biotechnology, Bioinformatics, or a related field.
• Overall experience of 9+ years of employment tenure.
• 5-6 years of experience in the life sciences domain.
• 3-4 years of experience in IT, specifically in the validation of scientific applications.
• Strong knowledge of LIMS and other scientific applications.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.

Preferred Skills:

• Experience with regulatory compliance (e.g., FDA, EMA).
• Knowledge of GxP, 21 CFR Part 11, and other relevant regulations.
• Familiarity with project management methodologies.
• Review operations and related controls provide assistance to Author applicable SOPs governing the CSV processes for BBL IT

Equal Opportunity Employer

Biocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.