MEENAKSHI PATHAK
BRISBANE,QLD
Summary
Quality Manager with deep experience in GMP-regulated manufacturing and quality systems across pharmaceutical and related industries. Leads deviations, CAPA, audits, validation, product release, and documentation control while coaching teams and improving inspection readiness and compliance.
Overview
2027
2027
years of professional experience
Work History
Quality Manager
Qphamra, EBOS Group
- Current
- Lead and maintain the Pharmaceutical Quality Management System.
- Ensure compliance with APVMA, TGA, ISO, PIC/S, WHO GMP, and internal quality requirements.
- Managed deviations, OOS, CAPA, change controls, complaints, and risk assessments to ensure adherence to quality standards.
- Oversee validation activities including cleaning validation, process validation, equipment qualification, and computer system validation.
- Review and approve SOPs, validation protocols, reports, specifications, and batch records.
- Coordinated regulatory inspections, customer audits, and internal audits to maintain compliance and facilitate transparency.
- Monitored quality metrics and implemented continuous improvement initiatives to enhance overall quality performance.
- Successfully led multiple validation projects and quality improvement initiatives.
- Provide leadership and coaching to QA personnel and cross-functional teams.
- Improved GMP inspection readiness through strengthened quality systems and audit programs.
Senior QA/QC Officer
Tripak Pharmaceuticals
09.2025 - 04.2026
- Reviewed and approved QMS documentation, including change controls, deviations, CAPAs, SOPs, specifications, and risk assessments, ensuring compliance with regulatory standards.
- Approved manufacturing and packaging process changes while monitoring their implementation to ensure adherence to quality standards.
- Oversaw onboarding processes for new products, preparing specifications, BoMs, and MPIs while managing validation activities such as test method, process, and cleaning validations.
- Participated in internal and external audits and supported the resolution of gaps.
- Acted as delegate for authorized person, overseeing release of finished goods in compliance with TGA regulations.
- Develop, review, approve, and maintain accurate production records for the manufacturing and packaging divisions.
- Support the Product Development division and technology transfer activities.
Toxicology Team Lead
Agilex Biolabs
12.2024 - 09.2025
- Oversaw laboratory operations for toxicology department, managing clinical pathology, dose preparation, sample storage, shipping, and analysis.
- Lead a team of scientists working together to achieve Agillex and client goals.
- Maintain efficient and high-quality processes within the Toxicology laboratory.
- Establish and monitor against key performance indicators.
- Coordinate laboratory-based activities to achieve Agillex and client goals.
- Ensure equipment and laboratory maintenance is completed as per established procedures.
- Managed CSV for assigned equipment.
- Preparation and review of standard operating procedures.
- Communicated with internal stakeholders, including study directors, to update on project status and timelines.
- Performed clinical pathology assessments.
- Conducted redundancy analysis to optimize resource allocation.
Research and Development lead
Sanofi Consumer healthcare
01.2020 - 10.2024
- Analytical Responsibilities:
- Method development for herbals and vitamins formulations using different analytical techniques using UV, HPLC, LC-MS and HPTLC
- Perform and write method validation and writing method to transfer to QC
- Developed and documented new analytical methods and protocols to enhance formulation processes.
- Write SOP, Stability protocols, technology transfer documents and testing methods for multivitamins and herbal products
- Raised CAPA, managed change controls, and documented deviations.
- Formulation Responsibilities:
- Development of nutraceutical products (tablets, capsules, and softgels), and preparation of their manufacturing instructions and work closely with the project managers to ensure the timely delivery of the project.
- Implementation of new QMS system in R&D to align with the other sites
- Introduced new raw materials to production site for formulation development.
- Prepared draft master formula and manufacturing documents, supporting factory to ensure successful batch production.
- Reviewed and monitored pilot batch documents, implementing changes to manufacturing processes based on observations from pilot batch evaluations.
QA Supervisor
Mylan Australia
02.2018 - 12.2019
- Lead operational strategy for QA team, aligning roles with company objectives and regulatory expectations.
- Ensure compliance with PIC/S GMP, TGA, GMP, and European Pharmacopoeia standards for domestic and export products.
- Oversee QA/QC functions including batch release, deviation investigations, CAPAs, complaints, and change control.
- Managed product recall processes, conducted risk assessments, and led root cause investigations with cross-functional teams to ensure compliance and product safety.
- Maintain and enhance the Quality Management System (QMS) to support continuous improvement.
- Collaborated with internal departments and external stakeholders to align quality initiatives with commercial targets, enhancing overall product standards.
- Oversaw supplier qualification and raw material testing protocols to maintain product integrity and ensure compliance with regulatory standards.
R&D Scientist (Contract part time)
Dermcare Vet Pty Ltd
01.2017 - 01.2018
- Developed and implemented continuous improvement opportunities in manufacturing and laboratory processes
- Managed deviation management system maintenance, ensuring compliance with regulatory standards
- Collaborated with departments to ensure timely completion of CAPA and change control, meeting site KPIs
- Worked to maintain and manage quality systems regarding cGMP for the site
- Supported or performed audit and inspections to assure compliance with regulations
- Helped In writing SOP, manufacturing documents, Batch documents, stability document, stability protocols and training material
- Stability data management raw material testing management, process validation and equipment validation and writing of validation records
Research officer, Inflammatory Bowel Diseases Group
Mater Medical Research Institute (MMRI)
01.2016 - 01.2017
- Contributed to clinical projects focused on inflammatory bowel disease, enhancing understanding of disease mechanisms.
- Lead team of Research students and assist them in their projects.
- Collected research data from various sources, ensuring compliance with ethical standards. and statistically analyzing research data and complex scientific literature, adhering to regulatory and ethical standards
- Preparing and maintaining SOPs, study protocols, study-specific databases and documents, training logs, drug and device logs, ensuring supplies and equipment for studies are in stock to control inventory.
- Managed TGA scheduled drugs and poisons according to regulatory requirements.
- Development of an analytical method for the detection of nucleotides in blood samples and bacterial samples using HPLC and LCMS.
- Development of the tablet formulation for a patent application
- Conducted tests on pharmaceutical products, including tablets and suppositories, to ensure quality and compliance with regulations. of the pharmaceutical products in the form of tablets and suppositories according to the BP, USP to provide data for patent application.
R&D Scientist
Albert David Ltd
Ghaziabad
07.2009 - 06.2010
- Contributed to industrial preclinical and clinical projects, advancing phase II clinical candidates.
- Developed methods using HPLC and LC-MS for repurposing clinical candidates in diabetes and cancer, including biomarker analysis.
- Planned, conducted, and interpreted formulation and process development experiments.
- Managed small volume parental sterile preparations, including eye drops, ear drops, and infusions.
- Reviewed the current formulations and development of new formulations
- Conducted stability testing on final products to assess their shelf life. Analysis of data and prepare the report.
R&D Scientist
Ranbaxy
08.2006 - 06.2007
- Formulated solid, semisolid, and liquid products while adhering to GMP standards.
- Analyzed stability data to assess product efficacy.
- Supported timely delivery of studies through operational coordination.
- Assisted in securing necessary drug and non-drug supplies for clinical trials and processed site requests.
- Prepared or assisted in the preparation of clinical trial agreement and budget payment schedules.
- Planned technology transfer of the product from lab scale to production scale.
Education
Doctorate (PhD) -
The University of Queensland
Brisbane, Australia01-2016
Master of Pharmacy -
Kurukshetra University
Haryana, India01-2009
Bachelor of Pharmacy -
Guru Jambheshwar University of science and technology
Hisar, India01-2006
Skills
- Regulatory compliance
- Regulatory compliance training
- GMP and TGA knowledge
- Pharmaceutical manufacturing experience
- Change control and CAPA
- Method development and validation
- Scientific data analysis
- Documentation practices
Personal Information
Nationality: Australian
AWARDS AND HONOURS
Best oral presentation in 2015 in a conference help in University of Otago, Dunedin., Australian Research Scholarship, The University of Queensland (2011-2015), Conference travel award: School of Pharmacy, University of Queensland, Australia (2015)., Best poster presentation award in Australian Pharmaceutical conference (FIP) 2015., Outstanding achievement award from Sanofi Health Care in 2020., Second runner up in 3-minute competition in The University of Queensland.
Timeline
Senior QA/QC Officer
Tripak Pharmaceuticals
09.2025 - 04.2026
Toxicology Team Lead
Agilex Biolabs
12.2024 - 09.2025
Research and Development lead
Sanofi Consumer healthcare
01.2020 - 10.2024
QA Supervisor
Mylan Australia
02.2018 - 12.2019
R&D Scientist (Contract part time)
Dermcare Vet Pty Ltd
01.2017 - 01.2018
Research officer, Inflammatory Bowel Diseases Group
Mater Medical Research Institute (MMRI)
01.2016 - 01.2017
R&D Scientist
Albert David Ltd
07.2009 - 06.2010
R&D Scientist
Ranbaxy
08.2006 - 06.2007
Quality Manager
Qphamra, EBOS Group
- Current
Doctorate (PhD) -
The University of Queensland
Master of Pharmacy -
Kurukshetra University
Bachelor of Pharmacy -
Guru Jambheshwar University of science and technology