Beschreibung
CMO QUALITY ENGINEER (External Quality Commercial Packaging)Start Date: ASAP
Duration: until , Extension possible
Location: Zug, CH
The main purpose of this job is to manage the Quality Activities 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 Iifecycle management in relation with contract manufacturing and support to asset functions such as review and approval of regulatory filings, for owned area of competence.
The CMO Quality Engineer is the point of contact with CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plant Team.
Responsibilities
Accountable on CMOs oversight
- Quality Operations activities management with CMO
- Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed
- Develop knowledge of the manufacturing line at contract organizations (CMOs) and provide technical support for the manufacture of product, in collaboration with SME
- Collaborate actively with CMO to sustain without disruption the supply chain
- Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with the companies' expectations
- Participate to technology transfer or improvements projects through validation and on-site presence
- Collect Key Process lndicators (KPI) and contribute to appropriate actions identification
- Support Quality management Review preparation, Annual product Review performance and Quality Agreement
Quality System
- Able to identify and drive improvements/updates of the GMP documentation related to GEQ activities
- Able to identify any compliance gap in the companies' processes and escalate to management
- Support local Quallty system (change control, deviations, CAPAs, ...) as required
- Ensure adherence to serialization and data integrity requirements
Communication & Build Strategic Work relationship
- Identify and timely communicate to the management any supply risk or risk of batch rejection
- Ability to successfully influence the peer level at CMOs.
- Able to clearly communicate expectations to internal/external customers as well as management or peers
- Able to report status of ongoing activities to the manager/stakeholder, highlight any time constraints and propose action/time reallocation to the manager
- Develop and sustain an internal and external networking
Decision Making
- ldentifies, analyzes and solves problems in collaboration with SMEs
- Ability to back-up peers for area of expertise
Qualifications
- Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- A minimum of 5 years of experience in pharmaceutical or biotechnology industries
- Relevant experience in either manufacturing, development, quality or regulatory;
- Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus);
- Knowledge of medical device regulations and unit operations for manufacturing of either parenteral or pharmaceuticals, is a plus.
- Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams
- Strong communication skills
- Ability to work in an international matrix environment
- Negotiation skills
- Ability to clearly articulate complex situation into resolution by providing path forward to the upper management
Keywords: QA, Quality Assurance, Biopharma, CAPA, regulatory filings, GMP, GxP, Project Management, Switzerland, Zug, Pharmaceuticals, CMO, FDA, EMA, Quality Management, regulations, Senior QA Associate
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.