QA Pharmacist
2 weeks ago
Bachelor's Degree in Pharmacy
3+ years' QA experience is essential
Documentation of quality investigations relating to pharmaceutical / medical device processes
Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes validations
Good technical writing skills and communication as well as presentation skills
Working knowledge of Microsoft Office
Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
Ensure Quality Assurance Auditing policies and procedures are kept up to date and aligned with Quality standards and Regulatory requirements.
Prepare and participate in Regulatory Quality Assessment Audits (RQA) and BOH Inspections to the country office, ensuring successful results, and timely implementation/closure of action plans.
Identify and manage routine Customer Quality complaints for commercial Drug Products in global complaints management system and interactions with the Contractor Quality organization if needed for ensuring that the investigation reports are appropriate and acceptable.
Contribute to quality assurance management team initiatives and objectives.
related processes and communicate those through reports, memos, files and presentations.
Implement and adhere to current Good Manufacturing Practices regulations and company policies.
Assist in the review of area documentation and perform trend analysis on data, controls and standards
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