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Senior Specialist- Qa

Pharmalex
PharmaLex
5+ years
Not Disclosed
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.


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