Senior QA Specialist, QA Operations

Lonza

Visp, Switzerland

As a member of the QA Operations Team, the QA Project Manager, Senior QA Specialist (f/m/d) supports in all matters of GMP compliance (e.g. representation in local and global Quality Boards, contact person for customers and compliance questions), promotes the adherence and continuous improvement of Quality Systems and ensures Quality oversight in the specified area.

Key responsibilities:

Representing the department Quality Assurance in cross-functional teams and ensuring and managing interfaces to different internal and external stakeholder
Assesses, reviews and approves quality records such as deviations, change controls, CAPAs, investigations, effectiveness checks, and extensions in line with valid SOPs
Authors, reviews and approves GMP-relevant documents and SOPs in the ownership of QA
Supports and participates in internal, customer and regulatory audits
Support customer communications, manage interactions in case of changes, deviations, out of specifications etc.
Review and approval of executed batch records, prepares batch release package for the Responsible Person / FvP, including recommendation on disposition status
Review and approval Master Batch Records
Support continuous improvements programs to establish effective Quality Management Systems

Key requirements:

Bachelor or Master Degree in life sciences (e.g. chemistry, biotechnology or a related field)
Significant work experience in the GMP-regulated industry; preferably in the following units: Production, QC or QA
Broad knowledge in Quality standards (e.g. ICH Q7, 21 CFR Part 11)
Availability to occasionally provide quality support outside of working hours
English language skills (written and spoken) are required, German is an advantage

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