QC Engineer
1 day ago
Responsibilities
- Support the execution of Quality lifecycle
- Maintain Site Quality Master plan, including oversight for the development, completion, logging and archiving of documentation on protocols, Quality Master Plans, and quality Summary Packages
- Generates the quality schedule, drives execution of workload and monitors performance to plan and tracks status of quality activities and documentation
- Approves quality protocols prior to execution of work, ensuring content is accurate and in a timely manner to meet schedule requirements
- Drive compliance of the sub- contractor's quality plans
- Oversee the development and lead the closure of key validation packages / stages. (DQ, IQ, OQ, PQ)
- Ensure validation packages are following Quality plan and standards
- Establish and maintain system lifecycle documentation (e.g. Validation
- Plans/URS/FRS/IQ/OQ/PQ/FAT/SAT/TM) and associated final reports
- Evaluates data from executed validation protocols and ensures summary reports are generated and approved, Ensuring quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables
- Establish quality compliance checklists, FAT checklists and others as required.
- Develop and present project status updates to relevant stakeholders
- Support development and tracking of project related training requirements
- Support HAZOP's, documentation squad checks, risk assessments, design reviews, workshops and other project related activities.
- Manage closeout of corrective actions associated with validation activities
- Develop project summary reports
- Generates or approves Quality Risk Assessment documents in relation to executed quality activities
- Ensure that the Change Control Procedure is implemented and maintained throughout the project lifecycle
- Manage the documentation handover packages
Requirements
- Bachelor's degree in Chemistry, Pharmacy, Biology, Biochemistry, or equivalent
- 5 years of experience in pharmaceutical quality control, quality assurance or production
- Relevant experience in operations management and execution
- Demonstrated proficiency and knowledge of CGMPs, industry validation practices, and change control practices
- Demonstrated ability to effectively write technical documents, including test plans, protocols and reports
Pharmaceutical Industry
Quality Control
Archiving
Risk Assessment
Quality Management
Change Management
Quality Assurance
Safety Compliance
GMP
Compliance
Quality Engineering
Audits
Change Control
Regulatory Requirements
Pumps
Life Sciences
Process Control
Manufacturing
Commissioning
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