Beschreibung
Role: QA Manager
Location: Schaffhausen, Switzerland
Job Type: Contract
Rate: Negotiable
Start Date: ASAP
Key Responsibilities:
Qualification of 3rd party suppliers (contract manufacturing organization, CMO) in EMEA who will receive ca. 10 API's, Schaffhausen in outsourcing
QA review & approval of tech transfer documents
QA support for process and method implementation at CMO
QA review of validation documents and on-site supporting during validation campaign
QA review and approval of executed batch records/manage delegation for batch record review
Execution of CMO qualification, ie audits, quality agreements, specification agreements, qualification statements, etc.
Monitoring of qualified CMO.
Additional tasks:
Align with other outsourcing projects from other sites.
Qualifications:
My client is looking for an initiative, flexible and analytical person who is willing to adopt changes positively, find constructive solutions, and can represent towards 3rd party suppliers. Organizational and communicative skills are essential, as well as teaming with 3rd party suppliers to identify and ensure that my clients best practices - or adequate - are utilized.
Qualification:
JJ PRO Engineering
GMP
JJ PRO IM
SAP R3
JJ PRO Scientific
Pharma Experience
Non Technical Skills and Additional Details:
Professional experience and skills are needed as follows:
University degree in a life science discipline, eg Chemistry, Pharmacy, Microbiology
4 years experience in pharmaceutical industry (production and/or quality department, laboratory or R&D)
Experience in managing external manufacturers
In depth knowledge of cGMPs in EU and US and ICH-regulations
Ideally 1-2 years experience as an auditor in pharmaceutical industry
Ability to work in a global Matrix environment
Fluent in English and German language
Knowledge of IT applications, eg MS Office and ideally SAP/Trackwise Non-Technical profile requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management