QA CSV Specialist

Job content

About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Job Description:Key Accountabilities:

• Owns all quality related responsibilities for the Computerized System Validation (CSV) activities of dedicated new facilities, equipment and utilities related to the GMP manufacturing of biologics & APIs.
• Representative of Quality in the CAPEX project organization in regards to CSV
• Reviews and releases of CSV documents and SOPs.
• Be a Subject Matter Expert (SME) and provides guidance and recommendations to internal or external customers

Summary:

• Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field
• Significant experience in the GMP regulated pharmaceutical industry; preferable in a role within a Quality Unit
• Broad knowledge in CSV, Data Integrity and related Guidelines (21 CFR Part 11, EU GMP Annex 11, GAMP5 and the underlying principles of each)
• Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
• Working knowledge of ERP (SAP), MES (Syncade) and DCS (DeltaV) is an advantage
• Excellent verbal, written and interpersonal communications skills
• Fluency in English, German would be an advantage.

Supervision Received:Close Supervision :

• The incumbent is assigned duties according to specified procedures and receives detailed instructions.
• Work is checked frequently.

Supervision:

• The incumbent performs a variety of routine work within established policies and procedures, and receives detailed instructions on new projects and assignments.

General Supervision:

• The incumbent normally receives little instruction on day-to-day work and receives general instructions on new assignments.

Direction:

• The incumbent establishes methods and procedures for attaining specific goals and objectives, and receives guidance in terms of broad goals.
• Only the final results of work are typically reviewed.

General Direction:

• The incumbent exercises wide latitude in determining objectives and approaches to critical assignments.

Education:Degree (required): BS Field of Study Chemical or Mechanical Engineering, Life Sciences, Materials Science or related discipline.Degree (preferred):MS Field of Study Computer Systems.Language(s):Required: English (Ability Level 2 - Business Fluent.)Preferred: German ( Ability Level 2 - Business Fluent.)RequirementsWork Experience:(What is the experience you would consider for this role?)

• Please note: If UK is secondary location NO years of experience should be included)

Area: Familiarity with business processes related to CSV and GMP biomanufacturing environment Level - Advanced. Competencies & Behaviors:Agility:

• Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond.
• Embraces new initiatives and drives successful implementation in his/her area.
• Adapts thinking and behavior to support change.
• Takes personal responsibility for promoting change in his/her area.
• Understands how to effectively engage others in the change processes.

Business Acumen:

• Uses knowledge of his/her business area and related areas to make correct and timely decisions.
• Uses knowledge of his/her own business area and related areas to identify and develop operational/financial improvements.

Collaboration:

• Works in partnership as an active member of his/her team and cross-functional working groups.
• Actively seeks out and shares different perspectives from a broad network and implements alternative approaches.

Customer Focus:

• Proactively seeks to understand internal/external customer and market needs.
• Manages internal and external customer relations professionally and effectively.

Driving Results:

• Establishes and consistently delivers on KPIs and challenging goals for him/herself and team.
• Proactively shares credit for successes.
• Ensures delivery excellence for own goals and those of his/her team.
• Regularly solicits, assesses and addresses feedback.

Leadership:

• Takes personal accountability for outcomes resulting from choices and behaviors of self.
• Seeks and provides feedback to support professional development.
• Takes personal accountability for defining and implementing his/her own development.
• Ensures clear and direct 2-way communication within his/her team and other organizations.

Skills:(What analytical capabilities or niche skillset does this role require?)

• PhD and Degree in Chemical or Mechanical Engineering, Life Sciences, Materials Science or related discipline.
• Familiarity with business processes related to CAPEX projects and GMP biomanufacturing environment Ability to work with stakeholders from different departments and with different backgrounds.
• Ability to solve problems, understanding details and strategic picture, providing practical solutions. Strong analytical and investigative skills.
• Strong project management skills.
• Self-motivated individual with demonstrated ability to lead and support highly cross-functional teams.
• Effective influencing skills. Ability to communicate quality and compliance requirements to varying levels and functions of the organization.
• Excellent communication and interpersonal skills.
• Strong collaborative mindset.
• Strong organizational skills, ability to balance multiple priorities simultaneously.