C&Q Specialist
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* *Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions
* We are seeking a C&Q Specialist with expertise in execute qualification activities around an OEM-driven retrofit to an existing GMP manufacturing isolator.
Responsibilities:
- Prepare and maintain all commissioning documentation.
- Coordinate execution with contractor and vendors.
- Maintain commissioning status reports.
- Coordinate closure of deficiencies.
- Participate in project meetings.
- Support turnover to Operations and Maintenance.
- Maintain commissioning records.
- Provide editable electronic copies of all deliverables.
- Provide final PDF copies of all approved deliverables.
- Bachelor Degree in Science or Engineering or related field.
- Background in pharmaceutical products manufacturing environmental specially in sterile packaging area.
- Experience in commissioning and qualification.
- Strong knowledge of cGMPs regulations.
- Startup and operational readiness experience.
- More than 5 years of experience in commissioning related projects.
- Experience in digital validation solutions.
- Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications.
- Bilingual (English & Spanish) Benefits
What We Offer
- Opportunities for learning, development, and professional growth.
- A collaborative and supportive work environment.
- The opportunity to work with industry-leading clients on impactful projects. Your information will be kept confidential according to EEO guidelines.
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