Sarah Searle
Port Elizabeth,South Africa
Summary
Accomplished quality assurance professional with extensive experience in international audits and internal self-inspections. Demonstrates sharp attention to detail and expertise in detailed trend analysis, risk assessment, and deviation investigations for both national and international products. Proficient in CAPA action responses, implementation plans, and SOP writing and review. Possesses comprehensive knowledge of quality elements involving manufacturing, packing, QC, stability, HVAC systems, and water plants. Skilled in AQL and IPC quality matters with a long-term understanding of regulatory requirements and MAH processes. Career goal: to leverage extensive skills in a challenging role that enhances product quality and compliance.
Overview
30
30
years of professional experience
8
8
years of post-secondary education
Work history
Quality Assurance Pharmacist - 2021 - Present
Aspen Pharmacare
09.2021 - Current
- Deviation review and assistance.
- Extensive investigation and report writing.
- Change Control review and approval.
- Extensive Third party communication and dealings with audits, CAPA plans and actions as well as QC changes.
- Extensive exposure to internation GMP and regulatory audits (Completed the Inspire Pharma lead auditor course - Oct 2023)
- Veeva QDocs approvals for BMIs and BMRs, Trial, Validation and CPV protocol and report reviews, deviation and QSMR tracking.
- FMEA and risk assessment formulation and review.
- Review and assistance in Validation protocols, reports and SOPs,
Manufacturing Technologist
Aspen Pharmacare
06.2009 - 09.2021
- Trouble shooting in manufacturing OSD, BMI and documentation design and review, technical report compilation, Trial Batch development, Process Validation and Continuous Process Verification (CPV) of products in liquid and solid manufacturing and production support. On average, 3 validation batches per month alongside trial batches and associated documentation.
- Extensive work involving Process Compliance assisting with Deviation and Change Control assistance.
QA release Pharmacist
Aspen Pharmacare
05.2008 - 05.2009
- Batch release, document auditing, analysis of QC results
Production Pharmacist
Aspen Pharmacare
02.2006 - 05.2008
- Line clearance, GMP, compression and granulation experience
Community Service Pharmacist
St. Albans Correctional Services Pharmacy
01.2005 - 02.2006
- Filling prescriptions, ordering, stock control
Production pharmacist
Aspen Pharmacare
01.2004 - 01.2005
- Oral Solid Dosage and Liquid manufacturing experience as well as OSD and Liquid packing.
Student externship
Medical Centre Pharmacy
12.2002 - 12.2002
- Operating as Pharmacist Assistant Post Basic.
Student externship
Village Pharmacy
12.2001 - 12.2001
- Operating as Pharmacist Assistant Post Basic
Shelly Beach Pharmacy
12.1997 - 01.2000
- Work experience obtained during weekends and school or university holidays
Village Pharmacy
06.1995 - 12.1995
- Work experience obtained during weekends and school or university holidays
Education
Matric Exemption - B aggregate
Port Shepstone High School
01.1994 - 01.1998
Bachelor of Pharmacy -
Rhodes University
Grahamstown 01.1999 - 01.2003
Skills
Sharp attention to detail
Detailed trend analysis
Risk assessment write up and review
Extensive CAPA action responses and implementation plans
Extensive international audit experience (auditee)
Internal self-inspection experience
Extensive Deviation investigations and review for both national and internation products
CPV performance and review
Knowledge on all elements of Quality involving manufacturing, packing, QC and stability
HVAC and water plant knowledge
Extensive work on AQL and IPC quality matters
SOP writing and review
Extensive investigation and report writing experience
Long term understanding and knowledge of regulatory requirements, MAH and regulatory bodies
Custom
- Mr. Michael Smith, Quality Consultant and former Head of Quality, Aspen Pharmacare, Gqeberha, Eastern Cape, 0832830343
- Mr. Mike Vrettos, Regional Risk and Security Manager, Aspen SA Operations, Gqeberha, Eastern Cape, 0824984677
- Mr. Ludwe Mnyani, Warehouse Manager, Aspen SA Operations, Gqeberha, Eastern Cape, 0797857530
- Ms. Yolandi Abrahams, Quality Control Laboratory Manager, Aspen SA Operations, Gqeberha, Eastern Cape, 0763999145
- Mrs. D Wicks, Ex Warden of Canterbury House and Manager of Student Bureau, Rhodes University, Grahamstown, Eastern Cape, 0466038653
Personal Information
ID Number: 8009240286081
Languages
English
Native
Timeline
Quality Assurance Pharmacist - 2021 - Present
Aspen Pharmacare
09.2021 - Current
Manufacturing Technologist
Aspen Pharmacare
06.2009 - 09.2021
QA release Pharmacist
Aspen Pharmacare
05.2008 - 05.2009
Production Pharmacist
Aspen Pharmacare
02.2006 - 05.2008
Community Service Pharmacist
St. Albans Correctional Services Pharmacy
01.2005 - 02.2006
Production pharmacist
Aspen Pharmacare
01.2004 - 01.2005
Student externship
Medical Centre Pharmacy
12.2002 - 12.2002
Student externship
Village Pharmacy
12.2001 - 12.2001
Bachelor of Pharmacy -
Rhodes University
01.1999 - 01.2003
Shelly Beach Pharmacy
12.1997 - 01.2000
Village Pharmacy
06.1995 - 12.1995
Matric Exemption - B aggregate
Port Shepstone High School
01.1994 - 01.1998
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