Quality Assurance Manager

GenevaFixeChimie, Pharma, Biotechnologie2019-03-27Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Quality Assurance Manager

The Role:

• To manage and lead the Quality Assurance team of a fast-growing Swiss based company, to lead the strategic and operational performance of the Quality Assurance department (Quality Assurance, ensuring the successful delivery of business strategy, Key Performance Indicators and objectives, while adhering to regulatory compliance and achieving commercial success).

• The Quality Assurance Manager reports directly to the Technical Director & Qualified Person and has responsibilities towards the QA department.

Responsibilities:

• Manage and lead team members of quality assurance team, while having a part of the work load from the team with hands on approach to lead by example.
• Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current GMP requirements.
• Acting as the main point of contact on all Quality matters, internally and externally.
• Supporting, participating and coordinating Swissmedic & other foreign inspections &/or audits, so as to maintaining Swissmedic authorizations as well as all health authorities compliance status under the supervision of the QP.
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost..
• Proactively ensuring that the supplier and subcontractor audits are performed and reported as scheduled.
• Ensuring that Quality Assurance meets &/or improves on budget, cost, volume and efficiency targets (KPIs), in line with the business objectives.
• Participate effectively to support routine operations, manufacturing activities, validation activities and logistics controls through the execution of various Quality defined tasks within different production areas and facilities, so as to guarantee the highest quality standards to the pharmaceutical products marketed.
• Detection, mitigation and preventing any risks that could negatively impact all the pharmaceutical dosage forms through implementing the Quality standards as per cGMP practices as well as the internal Quality management system standards.

Profile:

• Degree in Pharmacy &/or equivalent pharmaceutical sciences.
• 8+ years' experience in Quality Management System leadership within the EU and/or Switzerland.
• Experienced to support Qualified Person in accordance with swissmedic & EU directives.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Fully aware about the cGMP international standards, starting from Swissmedic regulations, through EU directives, and other competent health authorities standards as well as requirements.
• Strong analytical and problem solving abilities, common sense pragmatism, target focused.
• Hands-on approach, open minded with a 'can do' attitude.

Votre contact

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La référence de cette offre est JN -032019-295235 - HAID

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