Biocon Biologics Ltd Hiring Freshers & Experience

Key Responsibilities

1.) Maintain quality systems to support RND activities; and further improve the systems and maintain harmonised QMS practices at RND sites.

2.) Prepare and implement SOPs required for quality assurance processes, prepare quality system documents (e.g. quality manual, master file,etc.), and ensure document and data control.

3.) Prepare and review document(s), records(s), procedure documents, protocols, reports, equipment qualifications, etc. 4.)Prepare training plans, curricula, programs, and ensure training of RQA and RND personnel

5.)Perform vendor assessments; audits of vendors and contract research organizations; internal audits, report audits, and follow up for corrective and preventive actions.

6.) Ensure appropriate review, assessment, investigation of deviations and ensure appropriate review and verification of correcti ve and preventive actions.

7.) Ensure appropriate review and evaluation of change proposals

8.) Ensure appropriate archival of documents, records, books, equipment and procedure documents, and maintain updated inventories of archived material

9.) Review submission relevant documents, ensure accuracy of submitted data, and support with responses to queries and deficiencies 9.) Ensure readiness for audits and inspections at all times, coordinate and face audits and inspections, and help formulate response to audit and inspection observations

Any other assigned responsibility and to act as a Team Member-RQA-Clinical (when needed

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