Contract: length to be defined
The main purpose of this job is to manage the QA interface with manufacturing and testing partners for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.
The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements. The role also includes quality management of the product lifecycle management in relation with contract manufacturing, artworks and support to asset functions such as review and approval of regulatory filings.
Should have proficiencies with the Quality systems and business processes associated with automation and integration of testing and production systems.
Demonstrated ability to work autonomously and lead project
Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
Demonstrated problem solving skills
Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
Candidates with experience in drug substance (or API) and drug product are preferred.
Experience in participating in pharmaceutical technology transfer team
Additional Job Requirements:
Minimum education level : Bachelor or CFC in Sciences
Minimum 2 years of quality assurance and/or operation experience in pharmaceutical or biotech manufacturing environments.
Good experience of process transfer and improvement.
Strong working experience with GxP regulations
Randstad (Schweiz) AG