Quality Analyst
Quality Analyst
Posted on :
19-12-2024
Employer Active
1 Vacancy
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Job Description
Education:
- Bachelors degree or equivalent experience in a relevant field (e.g. Life Sciences Engineering Quality Management).
Experience:
- Minimum of 3 years of experience in quality assurance within a regulated industry such as in the pharmaceutical biotechnology or medical device industry.
- Experience with Quality Systems (e.g. change control deviations CAPA).
- Experience in computer system validation following GAMP 5.
- Experience with the SFLMS ALM and/or MasterControl is highly desirable.
- Experience with applications such as Documentum RegDesk ServiceNow TOSCA SAP and IT software tools (Cat 1) is a plus.
Knowledge Skills Abilities
- Advanced knowledge of quality regulatory and compliance including 21 CFR Partsrequirements Data Integrity ICH requirements and GAMP 5 or equivalent experience.
- Familiarity with IT frameworks approaches tools and methodologies such as agile waterfall GAMP ITIL SDLC COBIT and Computer Software Assurance (CSA) or equivalent experience.
- Must have an advanced understanding of the validation and qualification lifecycle and all applicable phases including planning testing reporting and change control.
- Excellent attention to detail and ability to identify errors inconsistencies and compliance gaps in documentation with the ability to propose practical solutions to address quality issues.
- Strong communication skills both written and verbal with the ability to effectively collaborate with crossfunctional teams.
- Ability to work independently take initiative and meet deadlines in a fastpaced and dynamic environment while managing multiple tasks.
- Ability to adapt to changing technologies and learn new software applications quickly.
Employment Type
Full Time
Key Skills
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