Consultant Compliance

3 days ago

Singapore Arcondis Full time

ABOUT ARCONDIS

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

MISSION

Tasks and responsibilities

Equipment qualifications, commissioning, and method validations
Preparation of qualification and validation plans for laboratory and production-related processes
Preparation and review of specifications and risk analyses
GMP-compliant documentation
Planning and execution of IQ-OQ-PQ
Processing of changes and deviations
Creation of Standard Operating Procedures (SOPs)
Maintenance and archiving of documents
Ensuring training standards
Support of pharmaceutical release laboratories in GMP activities
Support in business development

STUDIES

**Profile**:
Successfully completed scientific or technical studies (for example: Pharmacy, Biotechnology, Engineering, Chemistry)
At least 3 years practical experience in a pharmaceutical laboratory or production environment
Very good GMP knowledge and in-depth knowledge of other regulatory requirements
Practical experience in quality assurance
Professional experience in qualification of laboratory equipment and facilities is an advantage
Experience in method validation of analytical methods is an advantage
Experience in LIMS or MES environment is an advantage
Careful, self-contained, and responsible way of working
Very good English language skills as well as strong experience in working with computer systems
High degree of quality awareness, strong communication skills and the ability to work in interdisciplinary teams
Willingness to travel

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