QPI Expert

ProductLife Group

Viana do Castelo

On-site

EUR 70,000 - 90,000

Full time

2 days ago
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Job summary

ProductLife Group in Portugal invites a senior Quality & Pharmacovigilance professional to join our global life sciences team. You will lead client procedures, NC and CAPA lifecycle, and mentor OPS staff on quality processes.

With 8+ years in pharma PV/QA, you will support GVP audits, drive process mapping and gap analysis, and defend PLG standards with clients. Strong written and verbal communication and stakeholder collaboration are essential.

Qualifications

  • 8+ years in Quality + Pharmacovigilance in a Pharmaceutical industry.
  • Experience writing procedures, process mapping and gap analyses.
  • Experience supporting GVP audits and client engagements.

Responsibilities

  • Lead client procedures, NC and CAPA activities for clients.
  • Train OPS staff on Quality processes (e.g., NC/CAPA).
  • Draft procedures and perform process mapping and gap analyses.
  • Support and coordinate GVP audits and client meetings.

Skills

Client procedures
Staff training
Process mapping
GVP audits
Client leadership
Client facing

Education

Science degree

Tools

ENNOV
Trackwise
MasterControl
Veeva

Job description

Job Description

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Required experience

8 + years’ experience in a Quality + Pharmacovigilance roles in a Pharmaceutical industry.

Key Skills Required
  • Management of client specific procedures, NC and CAPA for client
  • Trainer of OPS staff on Quality process (e.g. NC/CAPA)
  • Writing of procedure, process mapping, gap analysis
  • Support of GVP audits
  • Ability to lead working group with clients, take minutes on flight, propose solution
  • Client facing to defend PLG process and find compromises
Required Technical Skills
  • PV training
  • Quality assurance specific training
  • Experience in using QMS tools (such as ENNOV, Trackwise, Mastercontrol, Veeva etc)
  • knowledge of methodologies such as ISO 9001 2015 standard, Six Sigma, Lean or CMM
  • Graphical process modeling methods and tools (Visio)
  • Skill in MS Office tools, Excel, SharePoint, Content Management tools
Soft Skills
  • Partnership mindset
  • Commitment to deadlines
  • Excellent written and oral communication skills
  • Communication with client
Required Education

Bachelor’s or higher graduate degree in a science related field, or equivalent experience.

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