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Job Description Summary
This role is responsible for providing QA auditing for the PDx business. This role will have a focus on auditing and Global Compliance support to the GMP manufacturing sites, GDP, PV, GCP and GLP related functions. This role reports directly to the Global Quality Assurance Audit Leader, GE HealthCare Quality - PDx. Suitable candidates should have experience in the Pharmaceutical industry.
Job Description Summary
This role is responsible for providing QA auditing for the PDx business. This role will have a focus on auditing and Global Compliance support to the GMP manufacturing sites, GDP, PV, GCP and GLP related functions. This role reports directly to the Global Quality Assurance Audit Leader, GE HealthCare Quality - PDx. Suitable candidates should have experience in the Pharmaceutical industry.
The role will perform audits on behalf of PDx QRA with a focus on GMP, GDP, GCP, PV and R&D functions. In this role insights and industry trends are to be proactively shared within PDx 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 all PDx departments including global clinical, R&D and PV. 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.
Responsibilities
Job Description
* 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
Qualifications
* Bachelor's degree and extensive experience within the pharmaceutical industry
* Strong communication skills
* Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities
* Superior ability to work with global, cross-functional teams
* Proven ability to drive operational excellence
Desired Skills
* Previous Auditing experience required.
* Knowledge of cGMP, GDP, GPvP, GCP and GLP required
* Experience in the Pharmaceutical industry
* Demonstrated experience with applying classic Quality tools.
* Experience interfacing with global regulatory agencies.
* Ability to comprehend and communicate key regulatory requirements and expectations
* Experience of collaboration, negotiation & conflict resolution skills
* 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
Location
This role needs to be preferably based in the UK or Europe to align with the core business locations and manufacturing sites. Specifically, to enable effective communication with Asia, Europe and America. Approximately 50-60% travel anticipated.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviours
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
Additional Information
Relocation Assistance Provided: No
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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