QA on the floor / Gæðaeftirlit á framleiðslugólfi

Við leitum að lausnamiðuðum og nákvæmum QA On‑the‑Floor (QA OTF) sérfræðingi til að veita rauntíma gæðaeftirlit í framleiðslu á virku efni (DSM) og lyfjavöru (DPM). Hlutverkið felst í að tryggja að farið sé eftir GMP/GDP/ALCOA kröfum með virkri viðveru á gólfi, yfirferð skjala og náinni samvinnu við framleiðsluteymi. Unnið er á vöktum.

(English)

We are looking for a hands‑on and detail‑oriented QA On‑the‑Floor (QA OTF) specialist to provide real‑time quality oversight in drug substance (DSM) and drug product (DPM) manufacturing areas. The role focuses on ensuring GMP/GDP/ALCOA compliance through active shop‑floor presence, documentation review, and close collaboration with manufacturing teams.

Scope & Responsibilities

• Act as the QA contact for DSM/DPM during rotational shifts and support batch or facility issues.

• Ensure compliance with GMP, GDP, ALCOA; guide operators and address deviations or corrections as needed.

• Perform routine shop‑floor monitoring and document observations per SOP.

• Review alarm logs (BRIEM) and critical MLOGs; escalate observations when required.

• Approve IPT/IPC failure assessments.

• Verify area readiness, line clearance, and area release for DSM/DPM.

• Support media fills, cell bank issuance, and AQL sampling.

• Manage reconciliation and archiving of MLOGs and QA‑OTF forms.

• Handle visual inspection kits and conduct area release checks pre/post shutdown.

• Contribute to inspection readiness, audits, and updates to QA‑OTF SOPs.

• Train new QA team members when needed.

Minimum Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.

• 2+ years of experience in GMP‑regulated pharmaceutical or biotech manufacturing.

• Solid understanding of quality systems, documentation standards, and regulatory expectations.

• Strong communication skills and a collaborative approach.

• Ability to work rotational shifts in a fast‑paced production environment.