Bpo Self-inspection and Senior Auditor

2 weeks ago

Macclesfield, United Kingdom AstraZeneca Full time

**Are you ready for a role where you get to mix your interest for Quality Auditing and leading people to ensure we have best in class processes? This is the perfect opportunity if you want to influence colleagues and lead change to create the global Self-Inspection program, whilst also certifying that AZ Suppliers are following correct regulations and procedures**
- At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person._

**Your Team**:
Global Quality Audit, GQA, is the center of excellence for QA GMP/GDP audits within AstraZeneca. The group underpins regulatory compliance strategy for AZ Supply by providing independent and expert GMP/GDP audits for AZ manufacturing sites, AZ Marketing Companies, external suppliers and CMO’s. We are also driving audit excellence and auditor capability throughout AZ Operations and transform internal and external GMP information into company knowledge.

Working within our Quality Compliance team you will lead as the global Self-Inspection Business Process Owner (BPO) and you will audit as a GQA Senior Auditor. The position is split approximately 50% Self-Inspection BPO and 50% GQA Senior auditor. This position can be placed in Södertälje, Sweden or Macclesfield, UK.

**What you will do**:
As Self-Inspection BPO, you will lead the global Self-Inspection program, including:

- Designing and driving the Self-Inspection program’s strategic direction
- Leading the global Self-Inspection network, instilling excellence in our AstraZeneca first line auditing program
- Managing the global Self-Inspection Governance Team (Regional Process Team) and driving continuous improvement
- Developing an enterprise network of capable and trained auditors, confident in their ability to discern and communicate license to operate risks
- Collaborating with Operations’ sites to ensure the program is meeting the sites’ needs and is implemented effectively

As a Senior Auditor you will perform complex audits, including:

- Planning, coordinating and conducting GMP/GDP audits of AZ suppliers of materials, packaging components, and finished drug products. Audits are conducted in accordance with cGMP’s, ISO Standards, IPEC, ICH and company procedures
- Conducting audits of internal AstraZeneca Operations to ensure compliance to cGMP’s and AstraZeneca standards.
- Providing technically justified and regulation based audit observations

Across both roles you will:

- Interpret audit observations, communicating trends and providing recommendations to address license to operate risks in a proactive manner
- Work closely with colleagues to assure a common understanding of cGMP
- Experience working in cross-cultural settings

**Essential for the role**:

- Appropriate scientific degree
- Minimum five years’ experience working within a pharmaceutical GMP environment
- Experience auditing in a GMP environment
- Experience leading improvement and change programs
- Embraces and demonstrates a diversity and inclusion approach and role models these behaviors for the organization.
- Excellent communication (written and verbal) skills and the ability to build effective working relationships.

**Desirable for the role**:

- Project management experience

**Why AstraZeneca**:
Play an integral part in realizing our purpose: delivering life-changing medicines. It’s by being digitally-enabled that we can make a bigger impact and contribution to society, the planet and our business. Feel the backing and investment of our leaders as we accelerate our Digital journey forward.

**Want to bring new ideas and fresh thinking to the table - brilliant We have one seat available, and we hope it’s yours.**

**Opening date: 2023-03-22**
**Closing Date: 2023-04-09**
**Competitive salary and benefits package on offer

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