Sales Consultant at Real Staffing - SThree
QA PL Drug Product Specialist
Duration: 8 months initial
Tasks:
* Supervise compliance and customer Quality Agreement (QAA) activities for Drug Product Visp.
* Establish and negotiate QAAs with Drug Product Services (DPS) and Drug Substance (DS) sites.
* Address QA-related questions, topics, and complaints from customers.
* Manage changes, deviations, technical complaints, and out-of-specification results.
* Represent QA in cross-functional teams and customer meetings during technical transfers.
* Act as QA contact for specific projects and manage routine follow-ups with customers.
* Support and approve project/product-specific risk assessments and regulatory gap assessments.
* Review and release product-specific documentation.
* Collaborate with QC-Project Leader (QC-PL) and MSAT for new product introductions (NPI).
* Assess, review, and approve quality records, including deviations, change control, CAPAs, and investigations.
* Author, review, and approve GMP-relevant documents and SOPs.
* Support continuous improvement programs for the Quality Management System.
Requirements:
* 5-10 years of experience in pharmaceutical or biotechnology industries.
* Strong QA and Quality Management Systems knowledge.
* Experience in establishing and negotiating QAAs.
* Ability to manage customer interactions and handle complaints.
* Understanding of risk assessments and regulatory requirements.
* Excellent communication and teamwork skills.
* Experience with GMP-relevant documents and SOPs.
* Ability to support continuous improvement programs.
* Fluency in English; proficiency in German is a plus.
* Proficiency in handling deviations, change control, CAPAs, and investigations.
* Collaboration with QC-Project Leaders and MSAT for new product introductions.
* Valid Swiss work permit or EU-Citizenship.
Seniority Level: Entry level
Employment Type: Full-time
Job Function: Quality Assurance
Industries: Pharmaceutical Manufacturing
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