Ruby Eappen
MONTMORENCY,VIC
Summary
A Quality Assurance expert with a 12 years of experience within pharmaceutical and medical device GxP (GMP, GDP, GCL and GLP) quality assurance field focused on developing and implementing improved methods to ensure business compliance, workflow and processes. Fully trained and certified Quality audit performing internal and external audits. Advanced skills in various Quality Management system and Inventory management related software such as SAP, Trackwise, Qliksense and Companion.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Supplier Quality Auditor
CSL Behring
09.2019 - Current
- Performed audits for Qualification and Requalification of suppliers and service providers for the CSL sites
- Preparing audit reports and reviewing CAPA provided by suppliers to ensure it complies with international and local regulatory requirements and CSL business needs
- Assist in the Supplier development process to support continuing CSL business needs
- Subject matter expert on supplier-related queries for CSL Behring sites
- Responsible for the management of supplier quality agreements
- Responsible and mentoring new hires,and other internal CSL stakeholders on Supplier Quality processes resulting in increased productivity.
- Supporting various stakeholders within CSL in strategic planning, execution and finalization during Onboarding and Offboarding of Supplier for Global CSL sites based on company policies/procedures, local, state, federal and international regulation
- Support External Supplier Quality Contract Manufacturing Organisation (CMO) for performing audits and Quality Agreement when required
- Provide data for Right First Time of Suppliers to CSL Quality Operations
- Support and Participate in Regulatory Inspection as a Supplier Quality expert for CSL Behring and other CSL sites where required
- Support in developing the annual Supplier audit plan by assessing risks and evaluating current regulatory requirements.
- Support in the management for CSL projects eg , BMF project(AZD1222, CSL451), Privigen, AlbuRx, Base Fractionation , CSL Melbourne, and Facility F etc
- Performing CSL Affiliates' supplier Qualification and requalification process and supporting the Local Quality Office (LQO) and Regional Quality officer (RQO) in supplier-related queries and decision-making
- Developing and managing key supplier quality metrics and providing input during Annual product quality reviews, Management reviews etc
- Support senior leadership and various stakeholders in evaluations of Supplier Quality related processes, policies and procedures by identifying control gaps in processes, procedures and systems through in-depth research and assessment and suggested methods for improvement.
Quality Assurance Specialist III
EMEA, Hologic Ltd
06.2017 - 07.2018
- Management of Quality Management system
- Project lead for the transition from ISO 13484:2003 to ISO 13485:2016 requirement
- Conducting internal and external auditing
- Developing, Reviewing and Implementation of policies and procedures
- Supporting EMEA sites in ensuring compliance with ISO 13485:2016 requirements and local medical device regulation
- Responsible for the training of staff
- Active participation in Regulatory Inspection
- Performing Risk Assessment for EMEA region
- Management CAPA and Deviation for Hologic EMEA region
- Project Lead for the acquisition of companies to integrate Hologic QMS
- Educated EMEA Hologic sites on specific QA standards and confirmed maintenance of standards.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies across EMEA region
- Collaborated with management to provide training on improved processes and assisted with creation and maintenance of quality training.
Quality Assurance Officer
Medicines Evaluation Unit
10.2016 - 06.2017
- Management of Quality Management system
- Conducting internal and external auditing
- Writing SOP's
- Assessment, selection and management of suppliers and contractors
- Conducting GMP manufacturing steps for clinical trial activities
- Ensuring compliance with GMP, GCLP & GCP, company SOPs and applicable legislation
- Responsible for the training of staff on GMP, GLP and GCP principles
- Active participation in Regulatory Inspection and Sponsor Audits
- Performing Risk Assessment
- Transition from ISO 9001:2008 to ISO 9001:2015
- Conducting Validation
- Handling the QMS for NHS trust (The NIHR Respiratory and Allergy Clinical Research Facility) by conducting audits, conducting management meetings to discuss quality updates and issues related to trials, implementing new SOP and updating previous SOPs
- CAPA and Deviation Management
- Label Creation and Approval for IMP
Quality Consultant
QRCC Consultants Ltd
06.2016 - 07.2016
- Providing quality consultancy services to clients of QRCC
- Helping clients achieve QMS by setting up procedures and processes in place
- Performing GCP Investigator site audit, Supplier audit and facility
- Audits
- Performing internal audits for QRCC to ensure that the services provided to clients are of high standards
- CAPA and Deviation Management for clients
Quality Assurance Manager
Cambridge Research In Real Life
12.2015 - 05.2016
- Management of the Quality Management system within RIRL and handling quality issues for pragmatic investigator-initiated studies in the respiratory field at UK primary care sites
- Writing quality-related SOP
- Conducting monitoring visits
- Implementing new procedures to improve business standards and liaising with the head of the relevant department to execute the planned Improvement opportunities
- Manage all aspects of the audit lifecycle from scheduling to closure
- Performing Investigator Site Audits under ICH regulations and guidelines
- Actively hosting and participating in all regulatory inspections and giving response of the inspection response on time
- CAPA and Deviation management
Deputy Quality Assurance Manager
Interport Ltd
01.2013 - 12.2014
- Management of Quality Management system (GMP and GDP experience)
- Conducting internal and external Auditing
- Wring SOP's
- Assessment, selection and management of suppliers and contractors
- Ensured team compliance with GMP & GDP, company SOPs and applicable legislation
- Responsible for the training of staff on GMP and GDP principles
- Active participation in Regulatory Inspection
- Performing Risk Assessment
- Implementation of ISO
- Conducting Validation
- CAPA and Deviation Management
- Conducting Temperature Mapping for site
- Conducting monthly Environmental Monitoring for sites
- Label Creation and Approval
- Assured consistent quality of production by implementing and enforcing automated practice systems.
Regulatory Affairs Officer
Interport Ltd
10.2012 - 01.2013
- GMP and GDP experience)
- Applying New drug license and license variation
- Label & Carton Creation and Approval
- Preparing Batch Packing record
- Liaising with regulatory authorities (EMA, MPA
- MHRA)
- Conducting routine regulatory Audit
Clinical Pharmacist
Al-Adaliya Hospital
01.2011 - 08.2011
- (Pharmacy experience)
- Dispensing of medicine, Patient counselling, Management of drug supply within pharmacy, Writing Reports.
- Partnered with physicians and other members of healthcare team to optimize patient care through effective use of medications.
- Educated patients on possible drug interactions, potential side effects and optimal methods of administration.
Education
Master of Science - Biopharmaceuticals
Kings College London
London, United KingdomBachelor of Science - Pharmacy
P.S.G College of Pharmacy
IndiaSkills
- Audit Process Management
- Root Cause Analysis
- Document Review
- Quality Assurance and Control
- Corrective Action Planning
- Documentation Management
- Inspections and Reviews
- Quality Standards Adherence
- Key Performance Indicators (KPIs)
- Product Auditing
- SOP Writing
- Contract Mangement
Certification
- Medical Device Lead Auditor Certified (June 2017),
- RQA Member (Since Oct 2016),
- GMP for IMPs (Feb 24 2017),
- Information Governance (Dec 2015);
- Responsible Person (March 2014); Lead Auditor (Oct 2015)
Timeline
Senior Supplier Quality Auditor
CSL Behring
09.2019 - Current
Quality Assurance Specialist III
EMEA, Hologic Ltd
06.2017 - 07.2018
Quality Assurance Officer
Medicines Evaluation Unit
10.2016 - 06.2017
Quality Consultant
QRCC Consultants Ltd
06.2016 - 07.2016
Quality Assurance Manager
Cambridge Research In Real Life
12.2015 - 05.2016
Deputy Quality Assurance Manager
Interport Ltd
01.2013 - 12.2014
Regulatory Affairs Officer
Interport Ltd
10.2012 - 01.2013
Clinical Pharmacist
Al-Adaliya Hospital
01.2011 - 08.2011
Master of Science - Biopharmaceuticals
Kings College London
Bachelor of Science - Pharmacy
P.S.G College of Pharmacy
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