Job Details
The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
Responsibilities
Assist the QA Manager in developing and implementing comprehensive QA protocols specific to vaccine R&D processes.
Ensure all activities comply with relevant regulatory standards (e.g., FDA, EMA, GxP).
Conduct internal audits and monitoring to ensure adherence to QA protocols.
Coordinate QA activities across different departments and sites to ensure consistency and alignment with QA standards.
Assist in the allocation of QA resources effectively to ensure all quality checkpoints are met.
Identify potential quality risks and support the development of contingency plans.
Address quality issues promptly, working with the QA Manager to ensure minimal impact on project timelines and outcomes.
Collaborate with R&D, clinical, regulatory, manufacturing, and commercial teams to ensure seamless execution of QA activities.
Facilitate communication and collaboration among QA team members and stakeholders.
Assist in organizing and leading regular QA status meetings, providing updates and addressing any issues or concerns.
Maintain accurate and up-to-date QA documentation, including protocols, audit reports, and meeting minutes.
Provide regular progress reports to the QA Manager and other stakeholders.
Ensure all QA activities adhere to GxP guidelines and regulatory expectations, maintaining high standards of quality assurance.
Support the development and implementation of training programs for staff on QA best practices and regulatory requirements.
Identify and implement best practices and process improvements to enhance the efficiency and effectiveness of QA processes.
Qualifications
M.Sc./M. Pharm/MTech (Biotech/Microbiology/Biochemistry)
Advanced degree preferred (Ph.D.)
5+ years" relevant work experience
Highly organized with excellent attention to detail,
Other Details
- Industry Medical / Healthcare
- Recruiter Details Indian Immunologicals Limited
- Job Tags quality assurance
- Job Type Full time
Recruiter Details
- Indian Immunologicals Limited
- Hyderabad
- hidden_email
- hidden_mobile
Company Details
Indian Immunologicals Limited
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