QA Officer - GDP

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Job Details

JOB PURPOSE

To support the business in compliance to GDP and GMP regulations ensuring that work is completed in a safe and efficient manner and meeting the agreed standards of quality, GDP, applicable GMP and service levels of the company, clients, and regulatory bodies.

Responsibilities:

• Provide Quality Assurance oversight of operational activities to ensure compliance with GDP, applicable GMP, ISO 9001, company procedures and client requirements
• Raise, investigate, review and manage deviations and corrective actions (CAPAs), supporting other departments where required
• Perform internal and supplier audits in line with the agreed audit schedule
• Support and host client and regulatory audits
• Generate, monitor and report quality metrics internally and to clients
• Attend client review meetings and provide updates on quality matters, deviations and continuous improvement activities
• Support the Change Control process, ensuring quality-critical changes are appropriately documented, reviewed and assessed
• Ensure quality incidents, customer/client complaints and deviations are appropriately recorded, investigated and followed through to completion
• Ensure corrective actions are completed within agreed timelines and effectiveness checks are performed where required
• Ensure quality documentation is appropriately approved, controlled, maintained and reviewed
• Maintain up-to-date knowledge of applicable regulations, procedures and client requirements, including Technical Agreements
• Review daily temperature records and ensure appropriate action is taken when required
• Ensure all QA activities and records are completed in accordance with relevant procedures and regulatory requirements
• Comply with applicable Standard Operating Procedures (SOPs) and Health & Safety requirements

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Requirements:

• Ideally educated to degree level or equivalent
• Previous Quality Assurance experience within a GDP and/or GMP-regulated environment
• Good working knowledge of Good Distribution Practice (GDP) regulations
• Knowledge of the UK pharmaceutical regulatory framework
• Experience managing or supporting deviations, CAPAs, quality incidents and change controls
• Experience supporting or conducting internal, supplier, client and/or regulatory audits
• Ability to work effectively with internal stakeholders, clients, vendors and suppliers
• Ability to maintain accurate, compliant quality documentation and records

Minimum Skills Required:

• Strong knowledge of GDP requirements and quality systems within a regulated pharmaceutical environment
• Previous practical QA experience in a GDP or GMP environment
• Strong written and verbal communication skills
• Effective planning, organisation and prioritisation skills
• Ability to investigate quality issues and apply sound judgement and problem-solving skills
• Strong attention to detail with a commitment to quality and continuous improvement
• Ability to influence and collaborate effectively with different stakeholders
• Confident interpersonal skills and the ability to communicate with clients and cross-functional teams
• Flexible, proactive and able to use initiative when making decisions

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

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Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned