Darum lohnt es sich
• Support a program (plan, prepare and execute) of internal and external audits for QRA.
• Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity.
• Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits.
• Support regulatory inspections and customer audits as a functional QA subject matter expert.
• Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed.
• Assure completion of vendor qualification and surveillance activities performed and documented as defined in global and functional procedures.
• Participates in the quality management system (QMS) improvements.
• Provide guidance and ensure that ‘CAPA’s are correctly set up to capture risk assessment, effective corrective and preventive actions and have the required evidence.
• Perform QA approvals of Quality Event records.
• Keep up to date with latest guidelines from MHRA, FDA, EMEA and other Regulatory bodies.
• Monitor legislation, implementing changes, and informing the company of any relevant changes.
• Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.
Requirements
• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 8 years of experience in pharmaceutical industry.)
• 6+ years of experience in the pharmaceutical industry
• Previous Auditing experience required.
• Experience interfacing with global regulatory agencies.
• Ability to comprehend and communicate key regulatory requirements and expectations
• Experience in collaboration, negotiation & conflict resolution skills
• Knowledge of GPvP, cGMP, and GDP
