Technical and Validation (CVQ) Manager

Technical and Validation (CQV) Manager

Macclesfield

Competitive Salary & Benefits

Would you like to apply your expertise to impact the Engineering in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

We’re leading the way in delivering Lean processes that drive greater efficiency and speed.

With a new state of the art sterile manufacturing facility under design and construction at our Macclesfield campus, this will aid us in delivering the future patient demand for AstraZeneca’s treatment for advanced prostate cancer. This is the only one of its kind globally. The manufacturing and packing process for this treatment is complex, relying on good aseptic technique to ensure the sterility of the drug and to avoid any risk of product contamination.

We believe this is an exciting new opportunity for a Technical and Validation (CQV) Manager to work within our sterile manufacturing New Assets Programme teams.

What you’ll do

As a CQV Manager, we’ll ask you to provide Process, Packaging and Device technical expertise to the programme in order to support the processing and syringe fill and assembly asset delivery as well as drive continuous process improvement.

As a key member of the operations team you’ll drive the delivery of the Packaging and Device Technical Support from final design through to start up and successful validation. You will define the specification for process, packaging components and devices based on existing specifications and transfer, establish, and validate the technical process. We’ll expect you to provide technical support, problem solving and continuous improvement to manufacturing teams focused on primary and secondary packaging.

Actively involved in the final design, commissioning, qualification and validation phases of the new asset introduction execution you will be accountable for process technical decisions and/ or the definition and implementation of any technical process changes post completion of operational qualification as required.

You’ll provide leadership in Problem Solving and will utilise Lean Tools, providing technical direction, advice and information to members of the Programme Team through all phases of the schedule.

Through collaboration with the sterile manufacturing team, site technical teams, global packaging and device networks and Qualification and Validation Communities of Practice you’ll identify and share standard methodology and incorporate into the programme strategy inclusive of anticipated technical regulatory requirements.

This role has a strong coaching element and responsibilities will also include providing technical coaching in standards required for packaging and device related recommendations for improvements.

  • focus on design qualification and the commissioning, qualification and validation operational deliverables – reviews/approvals & working through issues
  • ops reviewer and approver of C&Q documents in line with VP commitments (FAT/IQ/OQ/PQ)
  • delivery of operations responsibilities in the governance process for C&Q incl. self-inspections/audits
  • responsible for technical process definition for new assets
  • recruitment and capability development of Process and Packing Capability Owners

Essential Requirements:

  • Experience in pharmaceutical process, fill and assembly operations
  • Practical problem solving experience and skills using Lean/Six sigma techniques
  • Project and business process management experience
  • Technical and/or engineering capabilities
  • cGMP and regulatory knowledge
  • Experience in qualification and validation
  • Pharmaceutical and aseptic/sterile manufacture knowledge
  • Data driven evaluation of process performance for the purpose of identifying required problem solving, improvements and opportunities.
  • Degree level or equivalent in a relevant scientific or engineering subject area

Desirable:

  • An appropriate packaging related qualification (e.g. Institute of Packaging Diploma)
  • Certified lean six sigma green or black belt
  • Understanding and interpreting of Statistical Process Control and Process capability data, ability to write technical reports.
  • Knowledge of automated detection systems

Pioneer a new future to meet global healthcare challenges.

If you are excited by this opportunity, apply today!

Where can I find out more?

Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook: https://www.facebook.com/astrazenecacareers/

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

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