Cqv Qc Specialist
Il y a 2 mois
PharmEng Technology is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years.
Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.
PharmEng Technology is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.
PharmEng Europe is seeking a full-time experienced **CQV QC Specialist in France.**
**Job Overview**
- Responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the QA/QC department.
- Will be expected to perform activities related to commissioning, qualification, requalification, validation independently.
- Will be expected to perform physical-chemical and microbiological methods validations (endotoxins, mycoplasma, and another microbiological assay is a plus).
- This position will require availability to travel.
**Responsibilities**
- Commissioning, qualification, and requalification of new or existing laboratory equipment, services and systems following regulatory guidelines such as GMPs or FDA.
- Qualification of computerized and automation systems.
- Writing of the corresponding qualification documents such as IQ, OQ, PQ protocols and reports, risk assessments, and development protocols.
- Recommending to management as to the acceptance and release of qualified equipmentor systems.
- Supporting the generation and execution of all documentation related to validation studies for equipment,.
- Reviewing technical and quality system documents such as SOPs, Change Control, Deviation Reports, and Analytical Methods, ensuring any document changes meet quality and validation requirements and are in full compliance with regulations, standards and regulatory compliance issues.
- Providing technical assistance during investigations of equipment qualification and/or method validation issues and aid in the resolution of validation deviations, protocol discrepancies and non-conformities.
- Providing effective solutions for the management of system deviations and non-conformities through the CAPA System.
**Qualifications**
- Bachelor's degree in life-sciences (engineering, biology, chemistry, pharmacy).
- At least 3 years of experience in in Pharmaceutical / Biopharmaceutical industry, focused on QA/QC Laboratory.
- Practical experience with analytical methodology validation (physical-chemical and microbiological).
- Generation and overview qualification documents like DQ, IQ, OQ, PQ, SOPs.
- Hands on commissioning, qualification and validation experience in the following disciplines is needed:
- Laboratory Equipment qualification
- Microbiological and physicochemical methods validation (mycoplasma/endotoxins/sterility among others)
- Computer software validation
- Firm understanding of cGMP validation requirements / guidelines and familiarity with FDA regulatory requirements for the Pharmaceutical / Biopharmaceutical industry, Eu. Ph and USP.
- Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
- Experience with Microsoft Office Suite.
- Fluency in English and French is a must.
- EU citizenship mandatory.
**What we offer**
- Full-Time Position
- Competitive Salary
- Opportunities working for a global company.
- Private Healthcare
- Thirty (30) days Holiday
- Continuous Professional Improvement including, but not limited to, courses or seminars.
At PharmEng Technology, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical Devices, Modular Cleanrooms, Thermal Mapping, Training, Toxicology and Regulatory Affairs.
PharmEng Technology is a cGMP compliant leader with international offices in Canada, Spain, France, Germany, Austria, Switzerland, Italy, Belgium, Singapore, Malaysia, Indonesia, Taiwan, Ireland, Denmark, Brazil and USA and maintains strategic partnerships for extended capabilities internationally.
PharmEng Europe is seeking a full-time experienced **CQV Specialist in France.**
**Job Overview**
- Responsible for providing direct services to site Technical Services management, aiding to increase the
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