QA Operations Manager

vor 2 Wochen

Lausanne, Schweiz Axepta SA Vollzeit

My client a growing international medical device company is looking for a **Quality Operations Manager to join one of their office based in Vaud canton.**

**Responsibilities**:

- Direct and manage the QA operations team
- Coach and mentor employees to optimum performance, and recruit and interview qualified applicants, ensure appropriate new-hire training and orientation, and provide on-going training and development of Quality Team.
- Identify and/or facilitate implementation of quality improvements or projects in accordance with cGXP and applicable standards expectations and evolutions to improve compliance, quality levels, and improve operational efficiencies.
- Activities include, but are not limited to: creation, review, or approval and implementation of Standard Operating Procedures, creation and delivery of training, supporting resolution of quality issues and CAPAs
- Monitor quality metrics to identify systemic issues in the batch release process and assuring appropriate investigation, correction, and corrective and preventive action when needed.
- Support internal and external audit activities, to include pre-audit planning, including development of audit plans, audit execution and evaluation and post-audit follow up and recommendations.
- Ensure applicability of current company policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable global, federal, and local regulations

**Your profile**:

- Bachelor's Degree, preferably in Life Sciences, chemistry or related relevant degree. Equivalent combination of relevant education and applicable job experience may be considered
- Minimum 7+ years of Quality Assurance experience in a GXP related field within the biotechnology, biologics, or pharmaceutical industry
- Experience in leading a quality operations unit that operated in full compliance with global cGMP requirements and successfully managed inspections from major Health Authorities including USA, EMEA, Canada, Brazil.
- Experience reviewing and releasing Final Product
- Six Sigma green belt/black belt preferred.
- In-depth knowledge of cGMP, GDP, FDA Part 820 and ISO13485:2016 requirements
- Ability to interpret and relate Quality standards for implementation and review
- Solid understanding of Deviation, CAPA, Change Control processes
- Familiar with process improvement, Six Sigma, product and process validation, SPC.
- Business fluent English in written and spoken
- Proficient in MS Office products and in SAP

Branche: Pharma-Industrie

Funktion: Qualitätsprüfung

Führungsperson: Ja

Anstellungsart: Festanstellung

Karrierestufe: Management

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