Mayalagu Vanitha
Summary
Diligent Quality Manager with over nineteen years of experience making sure products and services meet internal and external standards. Skilled in planning, organizing, directing and leading the Quality department. Organized and analytical with excellent written and verbal communication skills.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Site Quality Manager
HOYA Technosurgical Corporation Singapore Branch
04.2021 - Current
- Key Responsibilities
- In charge of establishing the new manufacturing site's Quality Management System (QMS) and product quality. Among these are reducing production defects, providing a practical GMP guide for manufacturing teams, and increasing quality system maturity within the organization
- Other Responsibilities
- Responsible for transferring Technology and QMS systems from Japan Plant to Singapore's new facility.
- Responsible for establishing a Quality system suitable to the Singapore plant.
- Support the Japan Plant in customer audits and regulatory audits
- Responsible for the maintenance and certification of the manufacturing site
- Manage internal, external and supplier audit programs
- Lead and coordinate all customer audits
- Led the quality team to manage on‑site manufacturing QMS processes, including Design Transfer, Change Control, CAPA, Training, Risk Management, Validation.
- Non‑conformance Product Control and Quality Data Analysis Review, Supplier Management, and Documents/Record Control.
- Lead Projects for quality process improvement, analysis of product quality performance and reducing non-value-added systems/practices
- Monitor and analyze product quality performance and enforce improvement actions to minimize deficiency and potential non‑conformances.
- Improve the effectiveness of validation activities and enhance the qualification process by using improvement tools, statistical data analysis, and problem‑solving techniques.
- Ensure manufactured products follow current QMS, International/Industry standards and regulatory requirements
- Collaborate on consistency between HOTS manufacturing sites regarding product manufacturing system processes and specification requirements
- Provide quality engineering support to operations and ensure no disruption to material supplies and production
- Manage and develop a centre of excellence team that provides leadership, best manufacturing practices, research support and training for gaps
- Construct QAS to meet customer demands and ameliorate after the establishment.
- Authorize the final shipping decision of manufactured products
- Coordinate the activities for QA to produce manufactured products smoothly
- Appropriately implement technical education based on the QAS
- Manage and supervise quality‑related education based on the QAS
- Manage and oversee quality-related operations with customers, such as quality agreements, inspections, complaints, and CAPA
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Led the team of Quality assurance and Quality control to ensure that the right person was in the proper role
- Manage prioritization of team resources and deliverables
- Other activities as assigned by supervisor.
QA Lead
Sanofi Aventis Pte Ltd
09.2018 - 04.2021
- Responsible for Capacity increase projects, business continuity projects and related qualification and validation activities
- Responsible for quality oversight of the technical department. Supporting investigations, SOP/document review
- Management of change control as change control coordinator, responsible for review of changes, quality assessment, tracking for completion and closure of change controls
- Other Responsibilities
- Review of SOPs/master batch records/ specification /Laboratory methods and GMP-related documents per regulatory lings and GMP requirements
- Ensure GMP/regulatory compliance at the plant with the plant Manager.
- Conduct regular Quality audits that the Plant Quality
Systems comply with corporate procedures and all relevant regulatory and certification requirements. - Perform gap assessment for site SOPs to ensure compliance with Global directives.
- Deviation investigation, report writing and CAPA
implementation tracking. - SAP administrator for SAP QM Module,e.g., inspection plan, CoA, MIC etc.
- Preparation of Annual Product Review. Initiate and facilitates product annual Review activities.
- Conduct self-inspection of facilities, operations, and
procedures to assure conformance with GMPs and related regulatory requirements. - Qualification , approval, and audit of suppliers of raw materials, packaging materials, ancillary materials, contract manufacturers and contract testing laboratories to ensure they can supply a product that meets established requirements.
- Ensure safe working by practicing and communicating safety.
- Validation and qualification: review and approval of design qualification, Installation Qualification, Operational qualification and Performance qualification for facility and equipment.
- Cleaning Validation: review and approval of cleaning validation.
- Quality Risk assessment.
- Trending: Data collection and statistical analysis.
Sr QA Specialist
Pfizer Asia Pacific Pte Ltd
05.2014 - 09.2018
- Key Responsibilities
- Involved in New Product Introduction (NPI) projects and Technology Transfer from Pfizer Ireland to Singapore. Supported product-related registration strategies and Pre- approval Inspection readiness
- Involved in Campaign start-up FMEA discussion and approval of FMEA
- Other Responsibilities:
- Ensure that all required Quality procedures are in place to start manufacturing
- Ensure that all activities related to establishing manufacturing processes for API during the project phase comply with cGMP and applicable regulations
- Authorize campaign start-ups and changeovers and participate in facility walk downs
- Review and approve SOPs/Checklist, Master Batch records, Deviations/Events, Change controls, CAPA, equipment cleaning and process validation records
- Annual Product Reviews and Product Quality Reviews
- Participate in the general QA activities and assist in the different areas of the QA function (Compliance/Release/Change control)
- Manage quality issues and investigations (e.g., deviations, trends, OOS) with respective departments
- Authorize QA processes such as Production Process Orders, Conditional equipment releases, Room releases etc
- Prepare and review major system documentation to ensure consistency with quality
- Standards and deliverables related to department activities and other departments
- Involved in supplier qualification
- Receiving and reviewing customer complaints
- Perform investigations on complaints for confirmation of the defect and to pre-assess criticality
- Communicate with the customer and Head office about follow-up action, progress, and updates
- Conduct internal audits to assess the company quality management system and maintain and improve quality levels
- Technical Knowledge
- Good understanding of regulatory inspection requirements
- Good understanding of regulatory timeline management
- Trained Human Performance Investigator
- Site MIR (Manufacturing Investigation report) Module trainer
Sr QA Executive
Actavis Pte Ltd
03.2012 - 04.2014
- Key Responsibilities
- Ensure products manufactured are in full compliance with cGMP& regulatory requirements
- Review batch and quality documentation & assess whether the product is fit for release
- Other Responsibilities:
- Review and approve change control, deviation, and customer complaints report ensuring consistency with quality standards as and when required
- Working closely with the production team on GMP deviations to establish the root cause of the problem, including corrective action and preventive action (CAPA)
- Establish internal audit plans and execute such plans and follow-ups
- Assess, review & approve cGMP documentation and changes that may impact product quality, validation, and compliance
- Receiving and reviewing customer complaints
- Support and deploy a quality management system for the artwork and packaging material control process
- Check and approve redressing requirements of products and materials according to the client and regulatory requirements
- Verify correct execution of redressing activity against approved/updated redressing instructions
- Record inspection results and perform usage decisions and stock posting
- Issue necessary documents to facilitate release
- Updating of logs and trackers as required
- Prepare and review protocol for Method Validation, Process Validation, and Cleaning Validation Whenever required
- Review test reports/results, ensure that all laboratory documents are in constant compliance, and implement appropriate corrective and preventive measures
- Ensure all health and safety procedures are followed and comply with all mandatory training
- Generating and reviewing laboratory equipment qualification documents
- Conduct training on SOP, cGMP and other revised work instruction
- Develop training materials and deliver technical training to laboratory colleagues
- Examples, Training on Chromatographic techniques, good weighing practices, pH and pH meter, Specific gravity, Dissolution, and Water content.
Research Associate
Genovo Development Services Ltd, Medreich, Pte Ltd Group
07.2007 - 02.2012
- I started in Jul 2007 and took a year break in 2009 to complete my Master's degree, and continued in the same organization until 2012
- Key Responsibilities
- Active participation in Method Development and validation (RS, Assay, Dissolution, Content uniformity, Uniformity of dosage unit and Residue (Swab Recovery)of Various Pharmaceutical Products
- Involved in method development for Antihistamine tablets and Enteric-coated tablets by RP HPLC
- Calibration of Analytical Instruments like HPLC, Dissolution Apparatus, UV, FTIR
- Spectrophotometer, GC, Karl sher, pH Meter, Weighing Balance, and other analytical instruments
- Prepare method validation protocol, Cleaning Validation protocol (Specific and non‑ Specific analyte determination)
- Compile and prepare reports of comparator studies and stability studies
- Preparation and maintenance of working standards
- Preparation of SOP, STP and analytical‑related documents.
QA Executive
Grandix Pharma Pte Ltd
01.2003 - 05.2007
- Involved in product/process development steps in solid dosage forms
- Involved in Process verification and process validation of Solid dosage forms
- Preparation of Equipment and facility validation protocol and reports
- Process evaluation and selection, process optimization of solid dosage forms
- Evaluating the company’s product specifications and examining them with customer requirements
- Setting quality assurance compliance objectives to achieve the targets
- Promoting performance improvement and quality assurance programs throughout the organization
- Ensuring product compliance with international and national legislation and standards
- Understanding, evaluating, executing the tests and procedures correctly and investigating the product modifications
- Directing workers engaged in testing and measuring products, tabulating the data relating to product quality, materials
- Maintaining and setting up documentation and control procedures
- Determining relevant quality-associated training requirements and delivering training
- Writing management and technical systems reports.
Education
Master of Business Administration - Business Administration
University of Northumbria At Newcastle
London04.2022
M.Pharm - Master of Pharmaceutics
Tamil Nadu Dr. M.G.R.Medical University
Chennai04.2011
Bachelor of Pharmacy -
Tamil Nadu Dr. M.G.R.Medical University
Chennai-IndiaSkills
- Leadership
- Inspection Readiness
- Quality Control Management
- Quality Inspections
- Team Management
- Problem-Solving Ability
- Customer Satisfaction
Certification
- ISO 9001:2015 Certified Internal Auditor-2022
- Inventory Management for Smart Manufacturing (A STAR)-2023
- DEVELOP A RISK MANAGEMENT IMPLEMENTATION PLAN (NTUC)-2022
- Certified FMEA Coordinator (Sanofi Aventis Singapore Pte Ltd )-2018
- Certified Supplier Auditor (Sanofi )-2018
- Certified Human Performance Investigator(Pfizer)-2015
Reading, Yoga
I love reading and doing Yoga in my free time.
Timeline
Site Quality Manager
HOYA Technosurgical Corporation Singapore Branch
04.2021 - Current
QA Lead
Sanofi Aventis Pte Ltd
09.2018 - 04.2021
Sr QA Specialist
Pfizer Asia Pacific Pte Ltd
05.2014 - 09.2018
Sr QA Executive
Actavis Pte Ltd
03.2012 - 04.2014
Research Associate
Genovo Development Services Ltd, Medreich, Pte Ltd Group
07.2007 - 02.2012
QA Executive
Grandix Pharma Pte Ltd
01.2003 - 05.2007
Master of Business Administration - Business Administration
University of Northumbria At Newcastle
M.Pharm - Master of Pharmaceutics
Tamil Nadu Dr. M.G.R.Medical University
Bachelor of Pharmacy -
Tamil Nadu Dr. M.G.R.Medical University
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