Posted: 7 February
Offer description
Senior Quality Assurance Specialist
About Us:
PSC Biotech is a leading biotechnology consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations across multiple continents serving numerous clients worldwide.
We offer innovative cloud-based software solutions for quality management and regulatory inspections to the pharmaceuticals contract manufacturing industry providing metrology services to our clients."Take your Career to New Heights" Our unique selling point lies in aligning our employee value proposition with opportunities to work alongside talented professionals operating within the Pharma/Biotech sector.
Our permanent employment offers gives exposure working at top Pharmaceutical client sites within diverse cultural settings Employees are empowered through Learning & Development training programs offering mentorship guidance facilitating career progression We believe in fostering high-performing teams that meet expectations of scalability business unit deliverables remaining under budget adhering timelines Our Overview section outlines an exceptional opportunity as a member of our Quality team:
The Quality Team invites applications from experienced CQV Lead/Contractor for senior QA validation activities overseeing compliance current regulatory requirements GMP company SOPs Activities include validating qualification processes equipment systems facilities cleaning storage areas CTUs shipping managing QA Validations ensuring schedule adherence timely project delivery Maintaining understanding cGMP regulations supporting transitions phases sustainsQA aspects Technical Expertise:
1. BSc or BEng degree Scientific Engineering disciplines (e.g. biochemistry chemistry engineering)
2. Experienced ProfessionalsQuality EngineerQuality AssuranceValidation roles
In regulated FDA/EU environments Strong technical expertise required Excellent understanding validation needs CGMP production facility Advanced knowledge support skills (i.e.: troubleshooting root cause analysis trouble shooting) Requisite skills including multi-task fast-paced environments independently self-motivated planning organisational time-management capabilities critical thinking operate functional boundaries internal external Professional Requirements on-site Responsibility report:
Achieve high-quality oversight conducting qualification/validation tasks Sites Utilities Equipment Computerised Systems Cleaning Processes Manufacturing Storage Controlled Temperature Units Shipping Plans URS Assesses Protocols Reports Deviation events Adhere SOP specifications acceptance criteria available provide Regulatory inspection Client audit assistance oversee CQV activities maintain Facility status promote maintenance validate updated knowledge remain aware emerging developments governing body legislations initiatives International Standards coordination schedules detailed professional delivery guided excellence accomplished world-class workforce throughout Facilities Engagement Training Monitoring Industry continuity health hazards constant professionally supported interaction regarding peers
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