Pamela Flaherty
Summary
Ambitious and motivated science professional with a Bachelor of Science Degree in Biosciences with Biopharmaceuticals and a MSc in Business and Management. A balance of strong scientific information skills and techniques alongside business acumen and communication skills. Pursuing a challenging role within the pharmaceutical industry. Key skills include implementation/ qualification of protocols for equipment requirement within the lab, testing and reviewing within a GMP environment. Review and release of Drug Substance and Drug Product batches to market specific.
Overview
8
8
years of professional experience
Work History
Materials (Project Manager)
Alexion Manufacturing
Co. Dublin
09.2022 - Current
- Support technical transfer for clinical, PPQ and commercial manufacturing of biopharmaceuticals materials (Upstream and Downstream)
- SME for introduction of single use systems and assessments of their use in terms of extractables Leachable
- Support the Global Materials Science group in the technical transfer of materials raw materials, excipients, and singleuse systems
- Support, troubleshooting issues on equipment involved in upstream and downstream
- Use of MES, Delta V and PI Historian for process support and investigations (for trends and events)
- Applying of extractable & leachable risk analysis, chemical compatibility risk analysis, microbial control risk analysis
- Author and review technical material evaluations (risk assessments) to support new product transfers to site
- Author and review support documentation, process descriptions, gap assessments, protocols, reports, and strategy documents
- Lead Key Process changes using change control management system
- Lead Cross functional project to support site objectives.
- Provided continuous process improvement and preventive and corrective actions to facilitate operational efficiency.
- Conducted reviews of design documentation to verify compliance with quality assurance standards.
- Met project scope and delivery dates by planning optimal testing schedules.
QC Specialist
MSD
Co. Carlow
11.2018 - 08.2022
- Reviewing of incoming Drug Substance (DS) and Drug Product (DP) batches against the test specification and the current Analytical standard revision (aligns with appropriate pharmacopeias USP, EP and JP)
- Liaise with Global teams for oversight of CMOs for DS Receipt and Release and Analytical and Drug product working groups for DP testing and release
- Executing change controls and tasks (Trackwise/IPI) required for batch release and production
- Tailgate Qualification execution of protocols for incoming DS required for ID analysis
- New Product introduction (NPI) lead within the QC department from PPQ’s, FSS, Clinical to Commercial approval
- Participation in the Tech Transfer team for introduction of new method transfers representation of the quality team
- Qualification of Contract Laboratories and Oversight of External Laboratories for testing
- Participation in internal and external audits
- Investigating quality deviations required for batch release (Batch Record Review)
- Maintaining a strong relationship with other departments involved in Quality activities both internally and externally
- Assess and partake in global change controls, determine if regulatory impact or any impact to the site, follow through with changes
- Annual product review (APR) for investigations, Change controls and Data trending on all commercial products (Statistical Analysis)
- Quality Agreement review among the site network and external contracting laboratories
- Partake and chair daily/weekly tier meetings relating to Quality, DS, DP, Supply planning, and Analytical working groups for NPI
- Involvement in continuous improvement projects i.e paperless DS batch packs, electronic batch release and registration CoAs for regulatory agencies.
Quality Control Technician
MSD
Co. Carlow
04.2016 - 11.2018
- Responsibility of analytical testing with cleaning verification and validation samples
- Support and partake in, in-house and external audits within the laboratory
- Purchasing, receipt and testing of laboratory equipment related to cleaning verification ie TOC, Conductivity, HPLC
- Supervision of IOQ equipment and performance of PQ of cleaning verification equipment generation
- Oversight and Co-ordination of supplier vendors for cleaning verification/validation equipment alongside C&Q
- Generation of protocols to support PQ
- Reviewed and approved protocols required to support PQ testing
- Review of supplier qualification documentation to support IOQ
- Investigating quality deviations required for analytical testing
- Support introduction of equipment through laboratory change controls, authoring and reviewing of SOPs
- Maintaining a strong relationship within the operation production, laboratory team and management to ensure results are reviewed and approved within an expedite or required time frame
- Introduced a lean project, ‘rhythm wheel’ for testing within the analytical lab for cleaning verification and validation samples.
Quality Control Officer
Moyvalley Meats
08.2015 - 04.2016
- Top-quality food processing company adhering to high quality standards set out by Irish & EU legislation.
Education
Masters in Business and Management -
Trinity College Dublin
06.2015
Bachelor of Science (Honours) in Biosciences with Biopharmaceuticals -
IT Carlow
06.2014
Masters in Pharmaceutical Technical & Quality Systems (QP Certified) -
University College Cork
Skills
- Advanced IT skills in excel, word and power point
- IT systems include SAP, Nucleus LIMS, GLIMS, JMP, GMII, Empower, MES, EBR , Trackwise, PDM, IPI, Delta V, MCS and PI Vision
- Knowledge and understanding of QMS such as lean six sigma, ISO standards, RCAs, QRA, CAPAs
- Strong Communication and interpersonal skills
- Relationship building
- Empathy
- Trustworthy
- Project Management
- Risk Management
- Data Analysis
- Technical Support
- Protocol Review
- Decision-Making
- Collaborative Team Player
- SOP Writing
- System Administration
- Quality Processes
- Mastery of Quality Processes
Accomplishments
- Junior achievements program
- Leadership Skills
- Music Teacher
- Train the Trainer
Hobbies and Interests
- Business Awareness
- Problem solving
- Teamwork
- Planning and organisation
- Ability to work under stress
References
Referees available on request
Timeline
Materials (Project Manager)
Alexion Manufacturing
09.2022 - Current
QC Specialist
MSD
11.2018 - 08.2022
Quality Control Technician
MSD
04.2016 - 11.2018
Quality Control Officer
Moyvalley Meats
08.2015 - 04.2016
Masters in Business and Management -
Trinity College Dublin
Bachelor of Science (Honours) in Biosciences with Biopharmaceuticals -
IT Carlow
Masters in Pharmaceutical Technical & Quality Systems (QP Certified) -
University College Cork
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