Laura Tinley
Quality Assurance Specialist at Uniphar Group- Claim this Profile
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Topline Score
Bio
Credentials
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Therapeutic Counselling
-Jan, 1997- Oct, 2024 -
Customer Service Level 5
FETAC (Further Education and Training Awards Council) -
Pharmacy Services Level 2
NVQ
Experience
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Uniphar Group
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Ireland
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Quality Assurance Specialist
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Jun 2016 - Present
• Managing Product Recalls from initial recall notification through to reconciliation and close-out. • Developing, writing, reviewing and updating operating procedures, work instructions and standard forms, as required by the QMS and in harmony with current regulatory requirements. • Managing all controlled drug activities including import and export licences, annual licences, quarterly and annual returns reports, destruction load calculations and export. • Inspection of returned… Show more • Managing Product Recalls from initial recall notification through to reconciliation and close-out. • Developing, writing, reviewing and updating operating procedures, work instructions and standard forms, as required by the QMS and in harmony with current regulatory requirements. • Managing all controlled drug activities including import and export licences, annual licences, quarterly and annual returns reports, destruction load calculations and export. • Inspection of returned products and assessment of their suitability to be released for sale. • Developing and providing internal training in areas of Pharmacovigilance, Recalls and Quality Complaints. • Managing quarantine requests and internal and external mock recalls. • Acting as the main Uniphar contact for pharmacovigilance. • Recording and processing quality complaints, medical queries, adverse events and pharmacovigilance issues. • Approving product set-up from a quality perspective. • Involvement in deviations, CAPAs, risk assessments and change controls. • Preparing and reviewing Technical Agreements and Safety Data Exchange Agreements. • Participation in HPRA inspections and Principal audits. • Involvement in internal auditing and process review/improvement. • Participation in Project Work. • Involvement in the receipt of temperature-controlled deliveries and product release.
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Quality Assurance Administrator
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Dec 2013 - Jun 2016
• Development, implementation and management of new processes and procedures for Product Quality Complaints and Pharmacovigilance. • Development and improvement of the Product Recall procedure. • Management of Product Recalls from initial recall notification through to reconciliation and close-out. • Management of all controlled drug activities including import and export licences, annual licences, quarterly and annual returns reports, destruction load calculations and… Show more • Development, implementation and management of new processes and procedures for Product Quality Complaints and Pharmacovigilance. • Development and improvement of the Product Recall procedure. • Management of Product Recalls from initial recall notification through to reconciliation and close-out. • Management of all controlled drug activities including import and export licences, annual licences, quarterly and annual returns reports, destruction load calculations and export. • Inspection of returned products and assessment of their suitability to be released for sale. • Recording and processing quality complaints, medical queries, adverse events and pharmacovigilance issues. • Involvement in deviations and CAPAs. • Participation in HPRA inspections and Principal audits. • Approving product set-up from a quality perspective. • Carrying out Bona Fides checks on customers. • Reporting of Exempt Medicinal Products to the HPRA within 48 hours of receipt. • Monitoring the warehouse temperature and humidity. • Participation in Project Work. • Creation of a Controlled Drugs data base to facilitate HPRA reporting and CD destruction load calculations. • Creation and delivery of a Pharmacovigilance training module to all customer-facing staff in the company. • Developing, writing, reviewing and updating operating procedures, work instructions and standard forms, as required by the QMS and in harmony with current regulatory requirements.
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Customer Service and Support Agent
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Dec 2007 - Dec 2013
• Processing orders for hospitals, wholesalers, reps and direct-to-patients. • Resolving queries and problems related to orders, and effectively managing complaints.
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NHS
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Hospitals and Health Care
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700 & Above Employee
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Pharmacy Assistant
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Jan 2006 - Aug 2007
• Dispensing medication to outpatients and inpatients, issuing and packing stock items for wards and clinics. • Assisting in the preparation and packaging of aseptic products. • Monitoring environmental and microbiological conditions in the aseptic suite. • Testing and validating aseptic equipment, including isolators. • Dispensing medication to outpatients and inpatients, issuing and packing stock items for wards and clinics. • Assisting in the preparation and packaging of aseptic products. • Monitoring environmental and microbiological conditions in the aseptic suite. • Testing and validating aseptic equipment, including isolators.
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Education
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2001 - 2006
The Open University
Bachelor of Science - BS, Geological and Earth Sciences/Geosciences -
2007 - 2011
The Open University
Master of Science - MS, Pharmacology, Earth Systems and Science Communication
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