AstraZeneca

1 week ago

Specialist, External QC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

Support coordination and quality oversight of routine testing at external laboratories where Alexion products are evaluated. Provide analytical and technical support, method troubleshooting, and guidance for out-of-trend/specification investigations, APQRs, change controls, and CAPAs. Coordinate lab communications and onboarding, write and revise SOPs and transfer protocols, liaise with Regulatory, and ensure alignment of analytical test procedures and cGMP-compliant, accurate records. Lead audit/inspection readiness as needed.

Location: Ireland

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Coordinate and manage external laboratories via regular meetings and communications to support testing of Alexion products.
•Provide routine analytical and technical support, including onboarding (writing QAG) and guidance for complex analytical investigations.
•Facilitate communications and support investigations regarding deviations, change control, and laboratory investigations between external labs and Alexion staff.
•Review and support operation activities including APQRs, change controls, CAPAs, investigation reviews, and process improvements.
•Write/revise SOPs and transfer protocols and reports; support method transfer and troubleshooting while ensuring alignment of analytical test procedures and maintaining cGMP-compliant records.

Key Requirements

•Bachelor’s degree in a relevant scientific field.
•Minimum 3 years of experience in Quality Control.
•Understanding of relevant regulatory requirements (e.g., FDA, EMA) and quality control industry standards in pharmaceuticals.
•Strong interpersonal and communication skills to collaborate with internal and external stakeholders.
•Strong analytical and problem-solving skills, with the ability to make data-driven decisions.

Experience:3+ yearsPharmaceuticalsQuality controlQuality assurance

Education:Bachelor's in relevant scientific field

Skills:CommunicationInterpersonal skillsCollaborationAnalytical thinkingProblem-solving

Tech Stack:AICGMPSOPsAPQRsCAPAChange control

Company Brief

AstraZeneca

Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn

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AstraZeneca

1 week ago

Specialist, External QC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

Location: Ireland

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Coordinate and manage external laboratories via regular meetings and communications to support testing of Alexion products.
•Provide routine analytical and technical support, including onboarding (writing QAG) and guidance for complex analytical investigations.
•Facilitate communications and support investigations regarding deviations, change control, and laboratory investigations between external labs and Alexion staff.
•Review and support operation activities including APQRs, change controls, CAPAs, investigation reviews, and process improvements.
•Write/revise SOPs and transfer protocols and reports; support method transfer and troubleshooting while ensuring alignment of analytical test procedures and maintaining cGMP-compliant records.

Key Requirements

•Bachelor’s degree in a relevant scientific field.
•Minimum 3 years of experience in Quality Control.
•Understanding of relevant regulatory requirements (e.g., FDA, EMA) and quality control industry standards in pharmaceuticals.
•Strong interpersonal and communication skills to collaborate with internal and external stakeholders.
•Strong analytical and problem-solving skills, with the ability to make data-driven decisions.

Experience:3+ yearsPharmaceuticalsQuality controlQuality assurance

Education:Bachelor's in relevant scientific field

Skills:CommunicationInterpersonal skillsCollaborationAnalytical thinkingProblem-solving

Tech Stack:AICGMPSOPsAPQRsCAPAChange control

Company Brief

AstraZeneca

Industry: Pharmaceuticals

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Cambridge, United Kingdom

Founded: 1999

Glassdoor: 3.8

Website LinkedIn