24 months temporary qa specialist

şimdi başvur

iş ilanı detay

istanbul, ıstanbul (avrupa)
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iş tanımı

We are looking for a "24 Months Temporary QA Specialist" for our business partner which is an American biopharmaceutical company.

Supports development of the Affiliate’s Quality Management System (QMS), including generation of new Standard Operating Procedures (SOPs) and User Manuals.

Generates and revises controlled documentation. (e.g. procedures, work instructions, forms, specifications, protocols, reports, etc.)

Performs administration of the Quality Management System, including coordinating the distribution and maintenance for GxP documentation.

Supports the generation of monthly document control metrics.

Performs a variety of activities to ensure compliance with applicable regulatory requirements.

Interacts with other Affiliate departments to establish project priorities timelines, and provides support to these departments from a QA perspective.

Supports the Associate Director QA in Quality oversight activities with the Affiliates external partners. (CMO, 3PL)

Liaises with Ireland offices on any issues, providing relevant support, to ensure continued product supply to the Turkish market.

Provides support to internal and regulatory audits/inspections, as required.

Participates in the development of training materials and rollout of training onsite.

Conducts gap analyses and support risk assessments of processes procedures against relevant GDP guidelines as well as corporate standards, as required.

Participated in local and corporate projects and process improvement initiatives, as required.


Bachelor's Degree of Chemical Engineering, Chemistry, Biology, Pharmacy, or equivalent.

3-5 years relevant experience in pharma is preferred.

Good command of English.

Good computer skills.

Good knowledge on GMP and GDP for CAPA, Deviation and Change Control Management.

Demonstrates working knowledge of Document Control fundamentals, Quality Systems and GMP requirements. Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, Turkish MoH.

Good knowledge of regulatory compliance guidelines for drug manufacturing, packaging and distribution.
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