For our customer located in Rotkreuz/Switzerland we are currently looking for a: Quality Manager (m/f/x)
- Branch: Pharma
- Duration: 9 Months+
- Workload: 50%
- Gross Rate Range (given by client): 49-55,50 chf/h gross
- Typical monthly gross salary: 80h*52chf = 4160 chf gross
The QA Release Manager prevents quality or regulatory non-compliance issues which could lead to product stock-out / withdrawal or product approval delays. He/she takes ownership of processes connected to marketed products, e.g. batch release, complaints handling, deviation management, escalation management and health authority notifications, as delegated by the Responsible Person (FvP).
Tasks & Responsibilities
- Takes over process ownership within his/her team or where assigned. The process owner ensures the proper functioning, monitoring and continuous development of a process within our client and local legal requirements.
- Is responsible for the adequate handling of investigations and for the training of impacted employees, if required.
- Takes over the project lead for assigned projects.
- Acts as Subject Matter Expert (SME) in his/her own area of responsibility.
- Responsible for the adequate handling and investigation of deviations including their CAPAs.
- Is responsible for maintaining and updating the quality management system within his/her area of responsibility.
- Ensures readiness for all GxP regulatory inspections & audits and performs self- inspections according to plan.
- Meet Key Quality Indicators (KQI) in the own area of responsibility. Assess, report and proactively monitor Key Quality Indicators in the area of responsibility, maintain overview and ensure gaps are addressed appropriately.
- Foster and champion a quality culture and a quality mindset.
- In the following, the main areas of responsibility are listed (not conclusive):
- Batch Release: Responsible for the release and non-release of product batches of marketed goods as delegated by the Responsible Person (FvP).
- Returns: Responsible for the release and non-release of returned product, as delegated by the Responsible Person (FvP).
- Escalations: Is responsible for escalation and management of quality incidents. Represents the country in escalation calls, as delegated by the Responsible Person (FvP). This includes the follow-up on required activities for investigation and CAPAs as well as timely communication to local Health Authorities.
- Communication to Health Authorities: Is responsible for the timely communication with Health Authorities, as delegated by the Responsible Person (FvP).
- Interaction with stakeholders: Is responsible for the interaction and communication with internal (e.g. Customer Service / Regulatory Affairs / Supply Chain Management) and external (e.g. warehouse) stakeholders within own area of responsibility.
- Change Control (product / QA Release related): Is responsible to perform QA activities for product / QA Release related change requests.
- Launches: In case of more complex launches or quality issues: Represents local QA organization in the launch team, ensures QA activities for successful product launches.
- Master degree in pharmacy or comparable education/scientific background with experience in GxP area
- Fluency in German and English (oral and written), French as advantage
- Several (5) years professional experience in pharmaceutical industry, analytics, quality assurance, production, distribution or pharmacy.
- Strong interpersonal, communication, negotiation and problem solving skills.
- Strong project management skills, including simplification mindset, strategic thinking and ability to lead changes
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.