QA Associate - Validation

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:

·        Develop and maintain the site Validation Master Plan (sVMP)

·        Develop validation and qualification protocols and perform validation and qualification activities in accordance with the sVMP

·        Perform qualification and validation activities for quality-critical assets, in line with applicable change controls

·        Maintain accurate and complete records of all qualification, validation and other QA activities

·        Support ongoing compliance with GDP, applicable GMP, ISO 9001 and client requirements

·        Maintain up-to-date knowledge and understanding of applicable regulations

·        Ensure QA activities are carried out in accordance with established procedures and client instructions

·        Record, investigate and support the resolution of quality incidents, customer/client complaints and deviations, ensuring appropriate corrective actions are identified and completed within agreed timescales

·        Ensure quality documentation is appropriately approved, controlled and reviewed

·        Review daily and monthly temperature trends

·        Participate in client and regulatory audits, ensuring relevant documentation is complete and available and providing supporting information for quality decisions when required

·        Perform periodic Internal Compliance Inspections of operational areas, identifying opportunities for improvement and agreeing corrective actions with relevant process/area owners

·        Complete relevant Key Performance Indicators (KPIs) and report weekly performance measures

·        Support appropriate archiving and other QA documentation activities

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Requirements:

• Ideally educated to A-level or equivalent
• Ideally 3 years' experience working in a validation role within a GDP or GMP environment
• Understanding of GDP and GMP regulations
• Understanding of ISO 9001
• Ability to maintain knowledge of applicable regulatory and quality requirements
• Ability to work effectively in accordance with established procedures, quality systems and client requirements
• Ability to complete training in all relevant procedures within the first 6 months

Minimum Skills Required:

• Good understanding of validation and qualification activities within a regulated environment
• Strong attention to detail with the ability to maintain accurate and complete quality documentation
• Ability to plan, organise and prioritise multiple tasks effectively
• Strong communication skills, with the ability to communicate effectively at different levels within the organisation and with clients
• Ability to influence through clear, well-structured and rational arguments.
• Strong problem-solving skills and the ability to remain calm and focused under pressure
• Ability to use initiative, take ownership and see tasks through to completion
• Ability to build and maintain effective working relationships with clients, colleagues, vendors and suppliers
• Sound judgement and willingness to seek guidance when required
• Flexible, conscientious and committed to continuous improvement
• Confident and professional approach, demonstrating integrity and respect

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.

Full time

Affiliated Companies

Affiliated Companies: Alliance Healthcare Management Services Limited

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