Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
LEADERSHIP MANAGEMENT
Generic

Ameena Anjum

Grand Island,USA

Summary

Results-driven Quality Control Manager with a Doctorate in Chemistry and over 19 years of experience in the pharmaceutical industry, specializing in Quality Control, Analytical R&D, and Quality Assurance Compliance. Proven expertise in managing and leading teams to meet project timelines while ensuring adherence to regulatory standards such as ISO 9001:2015 and 21 CFR. Demonstrated success in implementing LEAN lab management processes, conducting method transfers and validations, and managing CAPA and Change Control initiatives. Adept at enhancing productivity through strategic planning and execution within biopharmaceuticals, aseptic manufacturing, and controlled substance environments.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Manager, Quality Control Chemistry

Fresenius Kabi USA LLC
07.2022 - Current
  • Manage and oversee Quality Control lab operations Finished Product Release, Stability, Reserves, Raw material and IQC.
  • Oversee sample management, testing, data review, validation, and method transfer, equipment validation, and associated projects.
  • Worked on cost effective projects towards digitalization of QC lab, LIMS optimization to align the reagents expiry, column inventory management in LIMS.
  • Monitor changing analytical chemistry requirements, methods and pharmaceutical changes and implement corrective actions to be taken in response to OOS/OOT investigations.
  • Oversight on establishment of strong GMP culture and establishing a safety, quality and continuous improvement focused mindset within the organization.
  • Leading several LEAN-Continuous Improvement Projects in streamlining QC processes across method Optimization, QC lab – paperless lab with all approvals fully electronic in LIMS, LabX, Empower, ICP/OES/MS etc.
  • 5S of Chemistry labs, Instrument Capacity model, Stability time point reduction, Stability protocols optimization etc.
  • Spearheaded the implementation of 5S methodology in the Chemistry department, resulting in a 20% efficiency improvement in lab processes and a 15% reduction in material waste.
  • Oversee and establish data integrity practices. Responsible to ensure the quality and reliability of analytical data used for product development, manufacturing, and regulatory submissions.
  • Implement procedures and controls to ensure the accuracy, reliability, and security of analytical data, including data acquisition, analysis, and reporting.
  • Quality approver on OOS/OOT/OOE investigations, deviations, and other quality events; control strategy and specification setting; impurities characterization; and shelf-life/retest date assignment.
  • Lead analysis and identification of root causes for Laboratory Investigations to define and implement Corrective and Preventive Actions (CAPAs/PAs)
  • Manage and oversee sit Stability program management, approve APQRs, Annual Reports trend analysis and Adverse Trend (AE) evaluations, Approve and drive Stability Testing Protocols (STP), Report and manage Product in Field investigations, work closely with Compliance.
  • Support Product launches/Life cycle management of products through reviewing stability commitments to FDA for alternate API, line transfer, stopper changes.
  • Oversight and management of Plant Shutdown activities by approving Environmental Monitoring reports for N2, OFA, WFI systems for Buildings and Systems release, guaranteeing quality control standards were met for Production lines Shutdown activities, Line decommissioning activities.
  • Work on technical documents for Regulatory Affairs on PAS submission, CBE 30, CBE 0 tracking/technical documents.
  • Define and execute inspection readiness activities. Draft Global and interna audit responses.
  • Identify opportunities for process improvement and implementing changes to enhance efficiency and compliance.
  • Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
  • Represent QC function during 3rd party, QP, and regulatory inspections.

Manager, Analytical Research & Development Lab

Cosmetica Laboratories Inc
09.2020 - 03.2022
  • Pioneered the establishment of a state-of-the-art Analytical R&D Laboratory and established Analytical method development/validation for SPF invitro testing for OTC drug products/formulas; Design; developed validation plan and validation protocols.
  • Engineered a comprehensive Quality Management System for the Analytical R&D Lab, standardizing validation/calibration procedures for the instruments. Worked with vendors on quotation and contracts for purchase of new lab equipment/chemicals/supplies, new lab set up, PM/PQ services.
  • Developed and executed a robust system for documenting OTC Drug Product Specifications on Master Batch Records and Raw Material specifications, resulting in a 50% faster completion time for clients' regulatory submissions.
  • Reviewed, analyzed, and approved 160+ finished product specifications, ensuring compliance with quality standards and regulatory requirements, contributing to an increase in product quality and customer satisfaction.
  • Authored, implemented and approved SOPs, change controls to streamline new procedures, data integrity and compliance with industry standards.
  • Negotiated and finalized contracts with key vendors to procure new lab equipment, chemicals, and supplies, resulting in a 15% cost savings and improved supply chain efficiency.
  • Formulated a comprehensive report on R&D departmental metrics and KPIs for the fiscal year; conducted a detailed Balance Scorecard calculation to evaluate department performance.

Supervisor, Quality Control Chemistry Lab Operations

Bimeda Inc
04.2019 - 09.2020
  • Supervised and directed quality control personnel through effective mentoring, coaching and work delegation.
  • Eleven Direct reports in this position. Conducted performance reviews.
  • Responsible for leading external QC activities, meeting delivery dates, and leading technical areas across all programs. Ensure appropriate adherence to cGMP requirements at CMOs.
  • Led Technology transfer activities for various sites of CMOs, reviewed and approved method transfer protocols.
  • Support QC/analytical aspects of new product launch, technology transfer and process-validation activities
  • Responsible for all activities related to providing required documentation, review and revision of procedures, specifications, forms, and supporting regulatory filing document.
  • Approved and released DP/DS Drug Products, Drug Substances, Cof A and Change Control documents in time to meet Production Batch release timelines and business needs.
  • Worked on investigating/writing up reports for OOS/OOT investigations, root cause analysis.
  • Reviewed/approved and oversaw closure of about 105 open deviations in a fiscal year and maintained to implement CAPA for error free root cause. Prepared reports/review and approval to meet QC Batch release timelines;
  • Collaborated with CMOs, CROs and CTLs, providing technical expertise in resolving Investigations and deviations, and on analytical method issues.
  • Coordinate relevant internal specification document updates to acquire CMC management approvals for shelf life/retest updates.
  • Prepared audit responses for FDA, EU, Health Canada Audit observations.
  • Prepared metrics for Out of specifications/deviations/ Microbial Data Deviations, OOS trend reports, system suitability trend reports, Water Activity Trend Reports for production operations.

Quality Assurance Specialist

Bimeda Inc
11.2018 - 03.2019
  • Performed QA review of non-sterile/sterile Manufacturing Batch Records and revised records as per CAPAs.
  • Worked on authoring Deviations, root cause analysis, determining appropriate CAPAs.
  • Performed self-inspection and monthly QC lab inspections, Production floor inspection.
  • Managed the Change Control Process by performing quality risk assessment of the changes.
  • Managed the monthly metrics for Change Control Process and prepared Annual/Semi-Annual Trend reports.
  • Applied A3 analysis and DMAIC principle to the change control process towards trending the metrics.
  • Liaised between quality control and other departments and contractors, providing project updates and consultation.

Quality Assurance Technical Specialist

Apotex Pharmachem Inc
03.2015 - 01.2018
  • Project Quality lead on Deviations/Non conformances, OOS/OOT Investigations, perform quality impact assessment through Trackwise Deviation system.
  • Global Lead on Global Technology Transfer activities, QA approver on method validation/method transfer protocols, cleaning method validation reports, inter site/intrasite method transfer reports.
  • Performed FMEA analysis of deviations for risk impact.
  • Worked on CAPA implementation in various departments and ensured appropriate Corrective actions are implemented towards timely closure of audit observations.
  • Audited Internal and external sites (Vendors, contract labs, Internal audits).
  • Prepared Health Canada and FDA regulatory audit responses reviewed responses from various departments and provided quality insight and technical expertise on development of CAPAs.
  • Prepared Internal Audit schedule for Data reliability audits.
  • Led and conducted Data Integrity audits on all the Lab systems across Analytical Operations/QC, AR&D, In-process Labs.
  • Prepared Risk Assessment reports for vendor status evaluation; Authored SOPs, OVI (Organic Volatile Impurities) certificates.

Analytical Research & Development, Associate-III

Apotex Pharmachem Inc
06.2012 - 02.2015
  • Project lead on various projects leading method development/ method validation activities supporting New Product development projects.
  • Competently developed and validated methods for various projects right from Raw material stage to Finished product stage in a timely manner.
  • Performed method validation using different analytical techniques on HPLC, UPLC, GC, ICP/OES, Ion Chromatograph, IC(Ion Chromatography), ICP/OES, Particle Size Analyzer, Auto titrator.
  • Prepared validation protocols, validation reports, and Raw material screening reports as per SOPs.Prepared vendor evaluation reports, Form 37 A preparation for vendor evaluation.

Analytical R&D Associate-II

Apotex Pharmachem Inc
08.2006 - 06.2012
  • Developed and validated methods for various projects right from raw material stage to finished product stage in a timely manner.
  • Performed method validation using different analytical techniques.
  • Worked through issues faced during method development by using systematic approach.Prepared validation protocols, validation reports, and Raw material screening reports. Participated as a project member in various projects.

Teaching Assistant

University of Toronto
03.2005 - 06.2005
  • Utilized expertise in chemistry to conduct lab practical, demonstrate experiments, explain handling of chemicals and monitor students to complete lab work. Leveraged interpersonal and communication skills to graduate and undergraduate students.

Postdoctoral Research Fellow in Chemistry, Department of Chemistry

University of Toronto
02.2004 - 03.2005
  • Completed Post Doctoral work project on design and experiments for kinetic studies of various reaction interfaces; Designed research projects and alternative approaches and discussed results with fellow researcher and Professor. Reported on data assessments in technical documentation and wrote research articles.

Education

Ph.D - Chemistry

01.2004

M.Sc (Masters of Sciences) - Chemistry

01.1997

B.Sc (Bachelor of Sciences) - Botany, Zoology, Chemistry

01.1994

Skills

  • Phase-appropriate method validation
  • Management of stability programs
  • Regulatory compliance audits
  • Experience in conducting data integrity audits
  • Regulatory compliance assessments
  • Drug Product/Drug substance method Transfer/development/validation
  • OOS/OOT Investigations/Deviations/ Non-conformances/ Customer Complaints resolution
  • CMO/CRO work management; Internal/external customer coordination/audit
  • Instrument qualification/Calibration
  • Team performance/ Staff training and development
  • 5S, A3 Analysis, Lean Management, Continuous Improvement
  • Interdepartmental Project management
  • FMEA Analysis/Risk management
  • CAPA management/implementation
  • Annual Product Reviews
  • Change Control Management
  • Instrumentation skills (HPLC, GC, UPLC, IC, ICP/OES, IR, UV/VIS, Particle Size)
  • Stability Protocols approvals
  • ISO 9001:2015 QMS, ISO 31000, cGMP
  • 21 CFR Part 11, 210, 211, GAMP5
  • ICH Q2, Q11, USP/EP
  • GMP/GLP/GDP procedures
  • Leadership, Quality Management System (QMS) statistical analysis using Minitab
  • Lab management/lab set up
  • Strong understanding of USP, EP, HPFBI, FDA, ICH, cGMPs, 21 CFR, MHRA guidelines
  • 21CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical device Directive, JPAL
  • Working experience on LIMS, SAP, SmartQC, ZenQMS, QAD, Trackwise, Coptis, Smart sheet, Etq systems Superior computer skills with proficiency in MS office, Power point excel, SharePoint

Websites

Certification

  • Lean Six Sigma Green Belt - McGill University, Canada - 2019
  • Lead QMS Auditor, ISO 9001:2015, Omnex Management &Consulting (Exemplar Global Certified) USA- 2021.
  • Quality Basics for Cell and Gene Therapy products- The University of Georgia, 2025
  • Risk Management Credential Certificate – American Society for Quality (ASQ), USA-2022
  • Lead Auditor, Data Integrity & Data Assurance – Apotex Inc, Canada- 2015
  • Pharma Regulatory Submissions, Labeling and Product Summaries - Academy of Applied Pharmaceutical Sciences 2025
  • Lead Investigator/Approver on deviations/OOS/non-conformances on Trackwise system, Apotex Inc, Canada – 2016
  • Quality Auditor certification- Module-I and II completed at Apotex Inc, Canada
  • QA/QC Diploma Certificate in Pharmaceutical Quality Assurance - Academy of Applied Pharmaceutical Sciences Toronto, Canada 2005
  • Certificate in Pharmaceutical Biotechnology-Academy of Applied Pharmaceutical Sciences, Toronto, Canada-2021

Timeline

Manager, Quality Control Chemistry

Fresenius Kabi USA LLC
07.2022 - Current

Manager, Analytical Research & Development Lab

Cosmetica Laboratories Inc
09.2020 - 03.2022

Supervisor, Quality Control Chemistry Lab Operations

Bimeda Inc
04.2019 - 09.2020

Quality Assurance Specialist

Bimeda Inc
11.2018 - 03.2019

Quality Assurance Technical Specialist

Apotex Pharmachem Inc
03.2015 - 01.2018

Analytical Research & Development, Associate-III

Apotex Pharmachem Inc
06.2012 - 02.2015

Analytical R&D Associate-II

Apotex Pharmachem Inc
08.2006 - 06.2012

Teaching Assistant

University of Toronto
03.2005 - 06.2005

Postdoctoral Research Fellow in Chemistry, Department of Chemistry

University of Toronto
02.2004 - 03.2005

B.Sc (Bachelor of Sciences) - Botany, Zoology, Chemistry

Ph.D - Chemistry

M.Sc (Masters of Sciences) - Chemistry

LEADERSHIP MANAGEMENT

  • Currently working as Manager, QC Chemistry
  • Previously worked in roles of Manager, Analytical Research & Development Lab, Supervisor Quality Control operations and as Quality Assurance- Lead positions
  • Hiring manager, conducting interviews, selection of candidates.
  • Experience in Quality Control and Analytical R&D: 14 years
  • Experience in Quality Assurance: 8 years
  • Manager Experience: 6 years

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