Overview
On Site
Full Time
Skills
Regulatory Compliance
Collaboration
Good Manufacturing Practice
Auditing
Life Sciences
Biotechnology
Pharmaceutical Industry
Assembly
ISO 9000
GMP
IQ
OQ
PQ
Documentation
Conflict Resolution
Problem Solving
Communication
Job Details
Responsibilities:
- Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly.
- Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements.
- Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR).
- Collaborate with cross-functional teams to ensure smooth execution of validation activities and resolve any issues or challenges encountered.
- Analyze test data and recommend improvements or changes to systems as necessary.
- Ensure that all validation activities comply with GMP (Good Manufacturing Practice) and other applicable regulations.
- Provide support during internal and external audits related to validation activities.
- Keep up to date with the latest industry standards and validation techniques.
- Bachelor's degree in engineering, Life Sciences, or a related field (or equivalent experience).
- Proven experience working in aseptic environments within the biotechnology or pharmaceutical industry.
- Minimum of [X] years of experience validating packaging lines, labelers, case packers, and low-speed pen assembly systems.
- Strong expertise in SEA Vision Yudoo and AVI systems validation.
- Familiarity with regulatory guidelines such as FDA, ISO, and GMP.
- Experience developing validation plans, IQ, OQ, PQ, and VSR documentation.
- Excellent troubleshooting and problem-solving skills.
- Strong communication skills, both written and verbal.
- Ability to work independently as well as part of a team.
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