Senior Specialist- Qa

5+ years

Not Disclosed

Poland Portugal

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here's a refined version of the job posting:

We’re Growing—Grow With Us!
Are you seeking a dynamic company with daily challenges and growth opportunities?

PharmaLex, a global leader in pharmaceutical consulting, specializes in drug and medical device approvals, market development, and comprehensive product lifecycle management.

We are currently hiring a Senior Specialist - QA to join our team and support the implementation of our global QA program across designated VDCs. This position plays a critical role in supporting our global Quality Management System (QMS).

Senior Specialist - QA

Location: Poland or Portugal (Remote, EU time zone)

Your Responsibilities

Key Tasks:

Contribute to and review the annual audit program and specific audit plans for designated VDC(s).
Develop and support CAPA plans addressing deviations, audit findings, non-conformities, and other quality issues, including risk assessments and root cause analyses.
Monitor VDC progress against CAPA plans and escalate issues as needed.
Support the maintenance of VDC-specific training matrices.
Manage the document lifecycle for designated VDC(s), ensuring compliance with QMS and regulatory requirements, and communicate periodic document review deadlines.
Support the change control process for designated VDC(s).
Maintain and monitor KPIs and other QMS performance metrics, highlighting trends and issues for VDC attention.
Coordinate and lead regular meetings with VDC stakeholders.
Collaborate with VDCs and Quality Strategy teams to identify and implement process improvement initiatives.
Provide support for the global QMS/eQMS and participate in departmental initiatives as required.

Your Profile

Minimum of 5 years of experience in a quality role, preferably involving quality management or change management.
Bachelor’s degree in a scientific discipline.
Familiarity with pertinent legislation and regulatory frameworks (ISO 9001 requirements preferred).
Strong organizational and analytical skills, with structured and lateral thinking abilities.
Results-driven, with excellent communication skills and a team-oriented mindset.
Proficiency in written and spoken English (mandatory).
Demonstrated ability to work independently and collaboratively in a cross-functional, global environment.
Experience working remotely in the EU time zone, preferably based in Poland, Portugal, or Bulgaria.

Why Join Us?

A collaborative and diverse work environment that fosters innovation and inclusivity.
Opportunities to work with a global team and address exciting challenges.
Flexible working hours to support work-life balance.
Interactions with nearly all branches of the company across five continents.
Extensive initiatives for personal development and professional training.

How to Apply:
If you’re ready to embrace this exciting challenge with PharmaLex, please submit your application online, including:

Your earliest possible start date.
Any visa requirements.
Salary expectations.

Contact Information:
For additional information, please don’t hesitate to reach out.

Note: Applications from agencies will only be considered with prior agreement for this specific job opportunity.

Would you like further customization or additions to this version?

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Senior Specialist- Qa

Job Description

Senior Specialist - QA

Your Responsibilities

Your Profile

Why Join Us?

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