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Support the Quality Manager in establishing, maintaining, and improving the QMS to aid business abidance to MWIAH Quality Policy.
Pro-actively support the business in all quality assurance activities relating to the QMS.
Aid the development of the wider non-operational business through working alongside relevant associates to assist them in embedding quality assurance processes and standards.
Lead the business quality risk management program through evolving current process, annual and interim review scheduling, ensuring escalation of any quality/critical control point failures and promoting completion of quality impact assessments as required to maintain business regulatory compliance.
Lead the business validation program. Engage with key stakeholders regularly, review and sign off validation reports, engage with relevant departments to ensure that recommendations are closed out and actions documented.
Support the Quality Engineers with quality risk management review and internal validation activities.
Support the business in change management through evolving current process, being actively involved in change impact assessment and promoting risk elimination/minimization as standard.
Lead all critical or high-risk quality incident escalations.
Support the Quality Manager in development and maintenance of systems for management of customer feedback resulting in MWI Error or formal complaints.
Lead the creation, improvement and review of quality standard operating procedures and work instructions. Promote document creation, improvement, and review throughout the business. Ensure documentation is in line with GDP and ISO 9001 standard requirements.
Maintain the internal audit program (GDP, ISO 9001, Customer & Supplier).
Ensure internal audit documentation and scheduling are in line with business requirement.
Have a lead role in external audits (Regulatory, Quality, Supplier & Customer) supporting the Quality Manager & Responsible Person as required.
Support the Quality Engineers in the preparation for internal and external audit.
Support the Quality Engineers in leading targeted activities towards the closure of audit actions to maintain business adherence to regulatory and ISO 9001 standards.
Maintain the portfolio of QTAs and support the Quality Engineers in ensuring processes are in place to fulfil requirements.
Build business-customer relationships regarding QTA requirements.
Support the Quality Manager in the cascade of QMS related business KPIs.
Drive functional data-driven activity through regular data review meetings to continuously improve service quality and regulatory compliance.
Lead quality continuous improvement, review quality trend data, propose and execute quality improvement projects utilizing lean and six sigma principles and promote throughout day-to-day activities within departmental teams.
Support all quality engagement programs and have an active role in quality education & training initiatives.
Always understand and comply with job relevant Companies Practice Standards.
Understand the Companies standard operating procedures and attend training sessions as appropriate.
The above list is not exhaustive, and you may be required to carry out any other reasonable task as requested, appropriate to the scope of the post.
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Experience, skills and knowledge requirements:
3+ yrs experience in Quality Management and associated systems.
Working knowledge and keen interest in compliance to ISO 9001 and GDP/GMP standards.
Responsible Person (RP) trained, or, a desire to fulfil such a role.
Ability to lead change through teams and peers.
A self-starter able to continually develop their professional self.
Strong analytical skills and ability to manipulate/understand data.
Experience and qualification in internal audit (externally recognized)
Experience in external audit, externally recognized qualification beneficial.
Experience and externally recognized qualification in risk management principles.
Effective communicator both in writing and verbally to all levels of associate
Ability to build sustainable, developmental relationships with internal stakeholders whose cooperation is vital to your success.
Ability to operate as a flexible team player.
Planning and organizational skills, with attention to detail
Intermediate/Advanced skills in Excel, Word, Outlook
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 timeCencora 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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