QA Manager

Role: QA Manager

Location: Schaffhausen, Switzerland

Job Type: Contract

Rate: Negotiable

Start Date: ASAP

Key
Responsibities:

• 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, i.e. 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, e.g.
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, e.g. 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