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CMO Quality Engineer
View: 191
Update day: 01-04-2024
Category: Quality Assurance / Quality Control
Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing
Position: Entry level
Job type: Contract
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Job content
Proclinical are recruiting a CMO Quality for a pharmaceutical establishment. This role is on a contract basis and is located in Baar. The client is focused on ground-breaking treatments within neuroscience.Responsibilities
- Accountable for working alongside with CMO to endure without disturbance the supply chain.
- Capable of recognising and instigating enhancements/apprises of the GMP documentation associated with GEQ activities.
- Might support the junior team members in interpreting team objectives.
- Produce and participate in the constantly refining projects.
- Capacity to classify any compliance gaps in the company’s processes and notify management if needed.
- Recognise and suitably converse to the management any supply hazards or risk of batch refusal.
- Capability of efficiently impacting the colleague level at CMOS.
- Responsible for Quality Operations activities supervision with CMO.
- Guarantee suitable remedial and deterrent activities are outlined, executed and that their efficiency is evaluated.
- Evolve knowledge on the production line at contract organisations (CMOs) and offer technical assistance for engineering the product in cooperation with SME.
- You will be able to distinctly convey expectations to internal/external clients as well as supervision or associates.
- Classify, investigate and resolve issues working with SMEs.
- Mentor colleagues and train other subdivisions on quality regulation and tools.
- Other duties may be assigned to the role.
- Educated to a degree level (ideally a Master’s) within a scientific discipline such as Pharmacy, Chemistry, Biology, Biochemistry etc.
- At least 3-5 years of experience working within either pharmaceutical or biotechnology industries.
- Pertinent experience in either manufacturing, development, quality or regulatory.
- Comprehension of cGXPs, quality systems and regulations such as FDA and EU, know-how of regulations in Japan or other countries would be beneficial to the role, but not essential.
- Would be advantageous to possess knowledge of regulations and manufacturing in medical devices.
- Prior experience in project management and capable of developing efficient working.
- Affiliations with internal and external sites and cross-function project teams.
- Former experience in CMO management is ideal but not crucial to the role.
- Able to operate within a global matrix environment.
- Solid mediation and communication capabilities.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#QACompliance
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Deadline: 16-05-2024
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