Global Quality Assurance Auditor, Pharmacovigilance
Job Description
Summary This role is responsible for providing QA auditing for the Pharmaceutical Diagnostics (PDx) business. This role will have a focus on auditing and Global Compliance support to the GMP manufacturing sites and Pharmacovigilance (PV) reputed company functions. Suitable candidates should have experience in the Pharmaceutical industry. The role will reputed company audits on behalf of CQA with a focus on GMP and PV. In this role insights and industry trends are to be proactively shared reputed company the organization to ensure reputed company compliance and early identification of areas for reputed company improvement. This role will provide analyses of audits / trends and support in the assessment and promotion of compliance reputed company PV QA. This role will be aware of changes to regulations, guidelines, and provide support and QA reputed company for any necessary updates to operating procedures, risk assessments and change controls for process changes as well as productivity / efficiency improvement initiatives.
Job Description
Roles and Responsibilities Support a program (plan, prepare and execute) of internal and external audits for QRA. Ensure reputed company 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 reputed company 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. reputed company QA approvals of Quality Event records. reputed company 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.
Required Qualifications
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 Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Demonstrated experience with applying classic Quality tools Experience interfacing with global regulatory agencies Change agent with energy, passion & enthusiasm to drive change Demonstrated effective interpersonal, teamwork & networking skills Ability to influence. Determine a position and argue it effectively reputed company the business context. Additional Information Relocation Assistance Provided: No Apply To This Job