Senior Quality Assurance Specialist

Lonza

Visp, Switzerland

In Visp, we are looking for a QA Specialist (f/m/d) to extend our team. You will report to the QA Operations Team lead Microbial and work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation.

Key responsibilities:

Owns all quality related responsibilities for the daily activities in the department to support API manufacturing processes for clinical and commercial supply:

Responsible in full for adherence with the quality agreement provisions;
Responsible to ensure all deviations are appropriately investigated and recorded;
Responsible to drive CAPA items to complete and timely completion;
Directs the investigations of customer product complaints and assures the completion of the appropriate documentation;
Performs assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required;
Ensures an efficient cGMP compliant life cycle management of all products manufactured;
Has the authority to make quality decisions for the project in internal and external meetings.

Execute quality compliance activities:

Compiling, verifying and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.;
Ensures that document are correct, adhere to information filed to the authorities and that revisions/reviews are done in a timely manner;
Assesses project-specific risks and internal adherence to cGMP by identifying areas of non-compliance through risk assessments and internal & external audits; SME for clients audits and participate in regulatory inspections of health authorities.

Single client contact point for all project related quality requests:

Providing cGMP guidance to all Lonza departments engaged in the production of active pharmaceutical products;
Works with our customers to ensure their Quality questions are answered and all quality relevant items are communicated to the clients in a timely manner;
Quality lead in weekly phone calls and during customer visits.

Other activities like:

Supports cGMP training programs to ensure all staff is being trained;
Trains and mentors junior Lonza employees to better accomplish and perform in their duties as quality professionals.

Key requirements:

Bachelor or Master of Science in life science (e.g. chemistry, biotechnology or other related field);
Experience in the GMP regulated pharmaceutical/API industry is an advantage;
Ability to identify non-compliance and gaps from quality standards;
Experience collaborating closely with different functions and departments;
Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive;
Fluency in English language and basic German skills are an advantage.

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