QA Validation Specialist
About this opportunity
This is what you will do:
The QA Validation Specialist performs review and approval activities to support validation activities in Alexion ARDU cGMP commercial and clinical requirements for the Alexion Manufacturing Facility. The responsibilities will include performing review and approval of validation documents such as policies, master plans, procedures, specifications, investigations, protocols and reports.
You will be responsible for:
Maintenance of a strong Quality culture throughout the project through operational activities.
Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations.
Participate in verification quality risk assessments and provide quality oversight to ensure
verification quality risk assessments are effectively maintained/controlled.
Ensure and participate in the Quality Assurance support to internal manufacturing and technical
groups. Review and approval of functional area documentation (SOP, Work Instructions,
Criticality Assessments, technical report and protocols).
Authoring, review and approval of QA validation -related procedures.
Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation).
Support the vendor quality management programme.
Complete Audits as required.
Develop and report quality metrics for validation/verification.
Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
You will need to have:
Primary Degree in Science
Post-graduate studies as appropriate to augment primary degree
3-5 years’ experience in Quality/validation environment. Drug Product and Drug Substance experience
Excellent attention to detail
Good communication, team work and problem solving skills
The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
As is typical of a pharmaceutical manufacturing-based role, employees must be able, with or without an accommodation to: frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE and uniforms; use a computer with a keyboard and mouse; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
Good knowledge of relevant computer packages e.g. Trackwise, SAP and Vault Quality
Date Posted
12-Aug-2026
Closing Date
25-Aug-2026
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 644 comparable Quality roles across 85 biopharma companies.
Salary context
110 of 644 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 644 comparable roles
+ 39 more countries
Seniority mix
309 of 644 peers have a known seniority level
Therapeutic area mix
0 of 644 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.