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) related functions. Suitable candidates should have experience in the Pharmaceutical industry.

The role will perform audits on behalf of CQA with a focus on PV. In this role insights and industry trends are to be proactively shared within the organization to ensure continued compliance and early identification of areas for continuous improvement.

This role will provide analyses of audits / trends and support in the assessment and promotion of compliance within PV QA. This role will be aware of changes to regulations, guidelines, and provide support and QA oversight 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 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.

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 GDPDesired 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 within the business context.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $-$ Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered…