Biocon Biologics | Manager
1 month ago
Role & responsibilitiesPrimary Responsibilities
To govern the start to end activities related to shipping validations for various product portfolio across the globe which triggers from regulatory, quality, partners/CMOs/improvement initiatives etc.,To manage shipping related notifications for temperature excursions, investigation for shipments crossed the established TOR limit and other non-compliances. To liaise with QA and other CFTs to timely closure of SRNs/Deviations and facilitate timely immediate disposition of batches to ensure product availability in market & patients.To understand the validation deliverables with regulatory and quality team and ensuring the same for timely completion to fulfil product filing.To enable various cost effective and improvement projects through risk assessment and QMS documents.To host and lead regulatory/customer audits to aim zero critical and major observations. To provide response to the audit observations and ensure it for timely closure.
Secondary Responsibilities
Ensure all QMS, SOPs and qualifications are delivered on time without any extensions.Initiate, Plan, review, track progress & measure QMS performance in line with approved SOPs/regulations and appropriate quality tools.Coordinate & Manage relationships with Internal & external stakeholders for flawless execution of QMS activities.Identify potential risks and develop strategies to mitigate them.To present FG -Logistics compliance functions to Senior leadership on monthly basis.To ensure all digital projects are effectively implemented with CFT collaboration.Handle regulatory, customer/consultants/Internal, statutory and safety audits and ensure compliance.To review URS, Risk Assessment, Impact Assessment, Protocols, and Reports for the equipment and facility qualification.Establishing and review of EHS objectives, targets and management programs in the department.To support quality team regarding QMS review, PQRs, Trend report, facility review reports etc.Timely escalation of the issues to senior management with respect to quality and safety.To Adherence to CGMP and EHS norms as per the outlaid procedures and regulatory guidelines.To ensure mandatory and periodic training are completed for self and team.Adhere to the company's policies and ensure to align the warehouse activities to meet the company's business goals.To provide timely response to all QA internal/external audit and implement CAPA holistically
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