Csr Document Control
Resume:
AUGUSTINE KWADWO SIAW-WOLFENSOHN
Number
Email:
*************@*****.**.**
Address:
Glen Burnie, MD 21060
PROFESSIONAL PROFILE
SUMMARY
Quality Assurance professional possessing 7+ years of experience in GMP environments.
Translates business vision into quality initiatives that enhances performance, productivity, and profitability.
Inspected and analyzed raw materials and several already manufactured biologics /pharmaceutical products utilizing.
Investigated deviations, access impact, leverage root cause analysis tools and liaise with cross functional teams to implement effective CAPAs.
Knowledgeable in GDP (Good Documentation Practices)
Excellent knowledge in Veeva. Uploading Workflows, Reviewing and Approving
Planned, developed, implemented, measured and reviewed a quality systems(EQMS)
SKILLS / EXPERTISE
Quality Assurance (QA)/Quality Control (QC)
Attention to Detail, Work in a collaborative team environment, Strong organizational skills and teamwork
Technical writing, Deviation Writing, Quality Investigation, CAPA
Good Interpersonal skills.
Analyze data and complete detailed reports with an attention to detail,
Work independently with little guidance or reliance written Standard Operating Procedures (SOPs), instructions and plan work schedules to meet goals.
Minimum supervision required on day-to-day activities and accomplished tasks.
Ability to multi-task and demonstrate diplomatic skills.
Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.
Ability to effectively present information and respond to questions from peers, management, suppliers and customers.
Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access, SharePoint).
Experience with electronic systems, including Track Wise and Veeva
JUNE, 2017
DEC, 2021
AMPONSAH EFAH PHARMACEUTICAL COMPANY LTD, KUMASI-GHANA
DEVIATION AND DOCUMENTATION SPECIALIST- (QUALITY ASSURANCE )
Acted as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
Participated in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
Acted as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.
Performed QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
Wrote, revised and approved GMP documentation as necessary
Worked cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner.
Participated in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
Guided personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
APR, 2014
MAY, 2017
Rosemont Pharmaceutical Limited, Rosemount House, York dale Industrial Park, Braithwaite Street, Leeds, LS119XE
QUALITY ASSURANCE SPECIALSIT
Revised company standard operating procedures as per internal and external customer requirements.
Assisted in review of cGMP-controlled documents as necessary.
Participated in resolving deviations associated with the Document Management System.
Ensured basic grammatical accuracy and completeness when revising documents.
Filed, tracked and archived of cGMP documentation.
Assisted in the coordination of document management systems.
Supported regulatory and client audits/inspections.
Worked under general supervision to meet department project goals.
Worked closely with various departments at client to resolve quality issues and provide support as needed.
Processed, distributed, and maintained controlled documentation (i.e., SOPs, SMPs, material specification, logbooks, etc.) using the established document control system.
Issuance of Batch Production Records for Manufacturing.
Formatted, tracked, and issue-controlled cGMP documents including SOPs, protocols, test records, logbooks and forms.
Assisted with entry of document related information into applicable tracking logs.
Other duties as assigned.
AUG, 2011
APR, 2014
AMPONSAH EFAH PHARMACEUTICAL COMPANY LTD, KUMASI-GHANA
QUALITY CONTROL STABILITY COORDINATOR/ANALYST
Planned, executed, and oversee inspection and testing of incoming and outgoing product to confirm quality conformance to specifications and quality deliverables
Assisted operations and local quality function in tracking, documenting, and reporting quality levels as well as CSR, environmental and health and safety goals/KPIs
Analyzed and investigated product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
Developed or updated company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints
Execution of duties for the stability program and related stability studies
Performed timely completion of stability time point pulls as per relevant protocols and stability
Maintained stability sample inventory and related metrics for current stability studies
Performed stability sample shipments to contract laboratories and/or sample storage vendors
Maintained stability chamber care, maintenance and support troubleshooting and temperature chart data interpretation.
Provided support on stability data trending in accordance with stability program SOPs guidelines
Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
AUG, 2008
APR, 2011
AMPONSAH EFAH PHARMACEUTICAL COMPANY LTD, KUMASI, GHANA
QUALITY ASSURANCE ANALYST
Performed visual, dimensional, and functional inspections
Conducted final review and approval of Development, QC, and manufacturing-related documentation prior to batch release approval
Delivered Training for new hire joining QA team
Managed and led teams on complex GxP compliance events
Approved Deviations, CAPA and Change Controls
Managed the execution, review and approval of qualification, validation, and tech transfer activities
EDUCATION
Bachelor’s Degree-Business Administration
University of Ghana, Legon- Ghana.
2009
Kumasi Polytechnic University-(HND-Marketing)
High School Diploma
Kumasi Polytechnic University, Kumasi-Ghana
Labone High School, Accra, Ghana
1999
1996
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