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Job Details

QA Associate – Validation

Location: South Normanton, Derbyshire, UK

Salary: £29,008.51 per annum

Working Hours: Monday to Friday, 9:00 AM – 5:00 PM

Company: Alloga, a Cencora Company UK

Job Title: QA Associate – Validation

Reports To: QA Manager

Direct Reports: None

Job Purpose: We are seeking a dedicated QA Associate – Validation to join our team at Alloga, a Cencora Company UK. In this role, you will play a crucial part in supporting the business in compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) regulations. Your focus will be on ensuring that all work is completed safely, efficiently, and to the highest quality standards as set by our company, clients, and regulatory bodies.

Key Tasks

Over-arching Principles of Working:

• Ensure all accidents and near misses are reported immediately to the Health & Safety Manager.
• Perform all QA department activities in accordance with company procedures and client instructions.
• Document all QA activities appropriately.

Validation Responsibilities:

• Develop and maintain the site Validation Master Plan (sVMP).
• Develop validation and qualification protocols.
• Perform qualification and validation activities in line with the sVMP.
• Conduct qualification and validation of quality-critical assets following applicable change controls.
• Record all qualification and validation activities accurately.
• Report weekly performance measures.

Compliance Responsibilities:

• Maintain a current understanding of relevant regulations.
• Ensure QA activities comply with defined procedures and client instructions, maintaining appropriate records.
• Record, investigate, and communicate quality incidents, client/customer complaints, and deviations.
• Ensure corrective actions are carried out within agreed timescales.
• Manage quality documents to ensure they are approved, controlled, and reviewed correctly.
• Prepare for and participate in audits, providing supporting data for quality decisions.

Additional Responsibilities:

• Review daily and monthly temperature trending.
• Participate in client and regulatory audits.
• Maintain records of QA activity and complete key performance indicators (KPIs) relevant to the role.
• Archive paperwork and manage the removal of TMDs for destruction.
• Perform periodic internal compliance inspections to identify improvement opportunities.

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Competencies

• Effective communication at all levels within Alloga UK and with clients.
• Ability to influence through rational arguments and compromise when necessary.
• Maintain composure under pressure and focus on problem resolution.
• Build and maintain harmonious working relationships with clients and colleagues.
• Demonstrate initiative, ownership, and task completion.

Personal Attributes

• Flexible approach to work with strong planning and prioritisation skills.
• Confident, enthusiastic, respectful, and exhibits integrity.
• Willingness to learn from mistakes and make sound decisions.
• Drive for success and self-development, with a conscientious attitude toward performance improvement.
• Excellent attention to detail.

Knowledge, Skills, and Experience Required

• Ideally educated to A-level or equivalent.
• A minimum of 3 years’ experience in a validation role within a GDP or GMP environment.
• Understanding of GDP and GMP regulations, as well as ISO 9001.
• Must complete training in all relevant procedures within 6 months.

Key Working Relationships

• Supervisors
• Managers
• Clients
• Vendors/Suppliers

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 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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