Xcenda
From Xcenda's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
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.
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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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
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
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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
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