Process Owner Qualification/Validation and Risk (Quality Assurance Associate)

AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Process Owner Qualification/Validation and Risk (Quality Assurance Associate)

Macclesfield

 

Take the responsibility to ensure our pipeline becomes a reality

 

Take the lead in ensuring the hard work from the rest of the business is realised, as we reliably get every medicine out to patients without challenge. We never give up in diligently ensuring our patients receive quality and safe medicines, responding to a large variety of, often complex, demands.

 

We are now looking to recruit an experienced Quality Professional, with a high level of technical knowledge in Risk, Qualification and Validation. Underpinned by process knowledge across a range of manufacturing areas with particular focus on key Pharmaceutical Quality Systems. The role takes ownership and governance of a critical quality process in a new customised digital platform.

 

What you'll do:

 

As Business Process Owner (BPO) you'll be the primary point of contact for QA matters related to the support of two Business Processes; Qualification/Validation and Quality Risk.

 

Taking accountability for how critical quality processes are implemented across the site, ultimately being responsible for procedural instruction and training required to ensure the site retains the required process capability.

 

As leader of the governance team you will work in the Process Network framework to communicate both to and from the governance team to the site leadership /regional organisation. You will chair networks responsible for ensuring continued process compliance whilst defining and delivering process improvement projects.

 

Hold accountability for collaborating in data analysis and report creation on quality metrics and key performance indicators related to area of responsibility. In addition, you will perform Process Maturity Assessments, striving to constantly improve the Pharmaceutical Quality System.

 

Support cross-functional colleagues in their day to day roles with associated Pharmaceutical Quality Systems, whilst acting as a subject matter expertise for the new customised digital validation platform; GVLMS in VEEVA.

 

Collaborate with regional governance teams to support routine process execution and business change. This may be to work with the governance team to support direction, definition and solution design in line with AZ Global Policies, with a view to delivering continuous improvement opportunities

 

Experienced in managing risk you will use evaluative judgement in complicated or novel situations, owning Business Continuity Plan for the process.

 

Have a direct involvement with regulatory inspections where you act as BPO for the site PQS.

Proactive by nature, you will look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whist ensuring an appropriate level of compliance.

 

Knowledgeable of evolving regulatory compliance practices and recommends implementation strategies to QALT, sharing best practice as appropriate.

 

Experience required:

  • Degree (or equivalent) qualification in a science / technical field such as Pharmacy, Chemistry, Biology or Engineering.

  • Prior experience in Good Manufacturing Practice (GMP)

  • Comprehensive knowledge of international GMP requirements /quality systems, GAMP and Pharmaceutical manufacturing/packing and testing technologies.

  • With a high level of technical process understanding across a range of manufacturing areas, you will hold a comprehensive working knowledge of regulatory interactions and compliance procedures and ability to apply this in an operations environment.

  • Strong influencing and negotiating skills

  • High level of customer focus and a strong ability to reinforce and maintain quality standards.

  • Comfortable managing a complex and changing workload.

  • Proficient in use of IT systems and comfortable in understanding their configuration and design.

 

There are so many fantastic employee benefits that AstraZeneca offer! A competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.

 

So, what’s next…

 

Are you already envisioning yourself in this role? Good, because we can’t wait to hear from you!

 

We look forward to receiving your application no later than midnight Monday 25th April

 

Competitive Salary and Benefits

 

Opening Date: 09/04/2022

Closing Date: 25/04/2022

 

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram: https://www.instagram.com/astrazeneca_careers/?hl=en

 

Apply now


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