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Job Description
About PSC Biotech
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.
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.
Employees 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.
POSITION SUMMARY:
The CSV Engineer or SDLC/Compliance Specialist will be responsible for planning, writing, implementing, and reviewing validation protocols and knowledgeable in SDLC and Change Management / Compliance related computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The incumbent is also responsible and accountable for the execution of the PSC mission, to maintain the integrity and professionalism of our products and services while enabling steady growth and development .
THE role will support the US Team on PST Time.
DUTIES AND RESPONSIBILITIES:
- Write, review, and approve of validation protocols, summary reports, SDLC, and SOPs related documentation.
- Review and approval of test execution/results.
- Involvement in creation and resolution process of incident/deviation.
- Maintain accurate validation and SDLC documentation.
- Keep up to date with advances in the field and the regulatory requirements.
- Involvement in review and updating of validation, SDLC, and SOPs documentation.
- Involvement in reviewing and approving change management related records.
- Review and analyze validation data compiling reports when required.
- Assist and recommend process upgrades and improvements in efficiency.
- Assist in implementation of validation improvements.
- Involvement in both internal audits and external inspections as required.
- Additional duties and responsibilities may be assigned from time to time.
Requirements
REQUIRED EDUCATION AND WORK EXPERIENCE:
4-7 years of experience in computer systems validation experience.
Strategic agility and action oriented with the ability to drive results.
Demonstrated strategic thinking and implementation skills.
Strong attention to details.
Ability to work with team or independently.
Ability to follow protocols and procedures.
Excellent written and oral presentation and communication skills.
Highly organized in planning and time management, with the ability to multi-task.
Has a solid understanding of validation documentation, IQ, OQ, PQ, RTM, Test Scripts, Summary Reports.
Knowledgeable in CSV/CSA applications and SDLC requirements.
Knowledgeable in Change Management
Knowledge of operating systems and MS Office desired.
DEMONSTRATED COMPETENCIES:
Relationship Building Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
Negotiation Skills Active listening, needs assessment, and presents visions to build a consensus.
Analytical Skills Identifies, researches, and demonstrates logical reasoning to communicate critical information.
Rational Persuasion Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
Interpersonal Awareness Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
Agility Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines.
Technical Expertise - The ability to demonstrate depth of knowledge and skill in a technical area
Innovation - The ability to develop, sponsor, or support the introduction of new, improved methods, products, procedures, or technologies.
REQUIRED EDUCATION AND WORK EXPERIENCE: Bachelor s Degree in Computer Science or Engineering or equivalent experience. 4-7 years of experience in computer systems validation experience. Strategic agility and action oriented with the ability to drive results. Demonstrated strategic thinking and implementation skills. Strong attention to details. Ability to work with team or independently. Ability to follow protocols and procedures. Excellent written and oral presentation and communication skills. Highly organized in planning and time management, with the ability to multi-task. Has a solid understanding of validation documentation, IQ, OQ, PQ, RTM, Test Scripts, Summary Reports. Knowledgeable in CSV/CSA applications and SDLC requirements. Knowledgeable in Change Management Knowledge of operating systems and MS Office desired. DEMONSTRATED COMPETENCIES: Relationship Building Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry. Negotiation Skills Active listening, needs assessment, and presents visions to build a consensus. Analytical Skills Identifies, researches, and demonstrates logical reasoning to communicate critical information. Rational Persuasion Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions. Interpersonal Awareness Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes. Agility Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines. Technical Expertise - The ability to demonstrate depth of knowledge and skill in a technical area Innovation - The ability to develop, sponsor, or support the introduction of new, improved methods, products, procedures, or technologies.
Employment Type
Full Time
Department / Functional Area
Key Skills
