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Manager, Quality Assurance

Alliance Healthcare -
South Normanton

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Job details

Full-time
4 days ago

Qualifications

Document control
ISTQB Certification
Non-conformance investigation
Employee relations case handling
Internal quality management system auditing
Compliance audits
ISO 9001
Complaint handling
Performance management
Analysis skills
Quality assurance
Bachelor's degree
Organisational skills
Employee performance appraisals
Supplier quality management
Supply chain quality assurance
Training & development
Business
Quality management system (QMS) implementation
Leadership
EU Good Distribution Practice (GDP)
Team motivation leadership
Internal quality assurance

Full job description

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

This role is in support of Cencora's third party logistics service in Europe operating through our Alloga business.

Key Tasks

To ensure that all direct reports adhere to the Company Health & Safety policies / standards at all times
To ensure that all accidents and near misses are reported immediately
Act as a company RP / WQP in accordance with the RP / WQP procedure.
To support the business in maintaining compliance to GDP, applicable GMP, ISO 9001 and client requirements by:
- Providing QA oversight for the AP5 & AP6 warehouses and, where named on a company Wholesale Distribution Authorisation, acting as an RP / WQP for the company
- Supporting or hosting MHRA inspections
- Maintaining knowledge of applicable regulations
- Maintaining awareness of client requirements as specified in respective Technical Agreements
- Ensuring that all QA department activity is performed in accordance with defined procedures and client instructions and where applicable appropriate records are maintained.
- Ensuring that quality incidents, client / customer complaints and deviations are appropriately recorded, investigated, corrective actions identified and communicated.
- Ensuring that all direct reports are trained in GDP and all relevant procedures
- Hosting client audits and managing any resultant findings and associated corrective actions in accordance with client expectations
- Ensuring documents are managed, approved, controlled and reviewed
- Ensuring changes are appropriately documented, reviewed, approved and controlled
- Performing internal and supplier audits
- Maintaining a system for recording medical and technical complaints and ensuring the timely communication of such complaints to clients
- Managing the internal audit program and supplier audit program including scheduling of audits, management of audit completion, reporting and follow up of audit findings and corrective actions
- Disposition of Returned products for clients as documented within respective Technical Agreements based upon Alloga criteria and any client specific requirements
- Alloga authorisation of client approved destructions
- Review and sign off of Customer Bona Fide checks
- Maintain a system for completion of sample inspection activities and representative sampling
- Reporting monthly performance measures
To manage direct reports by:
- Supporting and monitoring direct reports in the continuous development of their skills and ensuring all direct reports are sufficiently trained.
- Conducting regular performance reviews and at least once annually conducting a performance appraisal with each direct report.
- Managing departmental holidays, sickness and absence and performing return to work interviews for every occasion of sickness in line with the Company Procedure
- Disciplining direct reports in line with the Company Discipline and Grievance Procedure
To carry out any reasonable request from senior management as required and according to business needs commensurate with training and experience necessary to complete such a request in a compliant manner.

Required Education, Experience and Skills

Bachelor's degree in life sciences, business administration, supply chain, or a related field, or equivalent experience required.
5+ years of experience in quality assurance/quality management within a regulated and/or operational services environment (e.g., GxP/GDP, logistics/distribution, shared services, customer contact centers, or technology delivery preferred), or a related field required.
2+ years of experience in a management capacity required.
Thorough knowledge of regulatory compliance matters.
Ability to communicate effectively both orally and in writing.
Effective presentation skills.
Ability to train, motivate and direct the work of others.
Ability to plan and conduct effective meetings.
Strong analytical and mathematical skills.
Strong interpersonal and leadership skills.
Strong organizational skills; attention to detail.
Ability to meet deadlines and work in a production-driven environment.
Strong decision making skills.
Excellent problem solving skills; ability to resolve issues effectively and efficiently.

Certifications

Certified in ASQ Certified Quality Auditor (CQA), Certified Professional in Healthcare Quality (CPHQ), ISO 9001 Lead Auditor (QMS), or equivalent preferred.
Certified in Lean Six Sigma Green Belt or Black Belt certification preferred.
Certified in ISTQB Certified Tester – Foundation Level (CTFL) preferred.

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

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