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Manju
Quality & Compliance Manager
Contato
Competências
Demonstrated experience with SOP Authoring.
Demonstrated experience with Technical/Regulatory Documentation.
Demonstrated experience with Document Review & Finalization.
Demonstrated experience with Data Consistency & Integrity Checks.
Demonstrated experience with ISO/IEC 17025:2017.
Formação acadêmica
Resumo
Professional profile
Experiência
Quality & Compliance Manager
Authored and quality-controlled technical documentation and SOPs governing ~6,000 annual test records, ensuring document accuracy, consistency, and adherence to defined regulatory standards prior to distribution.. Acted as project lead and primary point of contact for 7 accredited facilities during document review cycles, coordinating cross-functional input from technical teams and external auditors, negotiating resolution timelines, and driving 100% closure of findings within fixed 30-day cycles.. Served as Authorised Signatory, personally reviewing and finalizing documents for regulatory submission accuracy and completeness before external release.. Led a 50-person team and mentored junior staff in SOP authorship and documentation standards, building department-wide templates and guidelines still in use.
Research Associate – Molecular Diagnostics & Documentation
Authored and finalized 150–200 validated diagnostic reports daily, applying structured review and quality-control checks against strict biosafety and public-health regulatory protocols within a ~2-day turnaround.. Reviewed data outputs (amplification curves, Ct values) for consistency and integrity before finalizing reports for regulatory and public health authorities, escalating discrepancies for resolution.
Scientist, Food Microbiology & Quality Documentation
Authored SOPs, quality manuals, and validation reports supporting NABL accreditation; led method validation studies producing documentation later used as the evidentiary basis for external accreditation review.. Directed internal audits and supervised a 5-person team, applying structured document review to close all findings within 30 days.
Career Break – Family Care
Took leave from full-time employment for family care responsibilities following the birth of a second child, without access to maternity leave. Returned directly into high-intensity pandemic diagnostics documentation work in mid-2020.