Senior Manager
Posted on :
10-04-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2402615
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory
Our goal is to skyrocket our clients success, and you can be a part of our team s Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your
We are firm believers in coaching and developing the next generation of industry leaders and As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and
At PSC Biotech , it s about more than just a job it s about your career and your
Your Role
We are looking for a Commissioning, Qualification, and Validation (CQV) The CQV Professional would work alongside a talented PSC Biotech Team in an exciting, developing and diverse biotechnology
- Commission, qualify, and validate GxP facilities, process and laboratory equipment and utilities in assigned
- Provide CQV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality
- Draft and execute validation documentation:
- Validation Project Plan
- Requirement Specification (URS, DS, FS)
- IQ and OQ Test Scripts
- IQ/OQ/PQ Protocols, as necessary
- Validation Summary Report
- Develop risk assessments associated with validation
- Execute process equipment and clean room
- Write reports summarizing system
- Clearly communicate all progress, updates, and action steps for assigned
Requirements
- Bachelors Degree in a relevant science or engineering field, or equivalent years of hands-on
- 3+ years experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP
- Sound industry knowledge, project proficiency, and autonomy ;
- Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment,
- Understands current risk-based validation
- Experience in authoring, revising, reviewing, and completing controlled documents for validation
- Experience with system impact assessment and risk
- Good knowledge of the code of GMP and PIC/S
- Previous experience in the Life Sciences Industry is
- Previous experience in GxP Industries are
- Must be adaptable, customer service oriented, have a positive
- Excellent organizational
- High attention to
- Must have strong written and verbal communication
Benefits
Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational Employment decisions will be made without regard to an applicant s, employee s, or intern s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by
#LI-AK1
Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on 3+ years experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP Sound industry knowledge, project proficiency, and autonomy Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment, Understands current risk-based validation Experience in authoring, revising, reviewing, and completing controlled documents for validation Experience with system impact assessment and risk Good knowledge of the code of GMP and PIC/S Previous experience in the Life Sciences Industry is Previous experience in GxP Industries are Must be adaptable, customer service oriented, have a positive Excellent organizational High attention to Must have strong written and verbal communication
Employment Type
Full Time
Company Industry
Department / Functional Area
Key Skills
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