
Senior Quality Assurance Specialist
2 days ago
As a Quality Assurance Manager, you will play a pivotal role in ensuring the highest standards of quality and compliance across all production processes.
Key Responsibilities:- Regulatory Compliance: Interpret and implement regulatory requirements such as Current Good Manufacturing Practices (CGMP), Good Laboratory Practices (GLP), equipment purchase, calibration, repair, and maintenance, stability guidelines, validation, cleaning validation, facilities, and other relevant regulations.
- Quality Planning: Organize, direct, control, and evaluate activities related to quality assurance, including supplier evaluation, annual contracts, and statistical data analysis.
- Quality Operations: Oversee budgeting, goal setting, and quality reporting for the Quality Assurance Department.
- Technical Coordination: Consult with equipment vendors and suppliers to prepare specifications, present proposals, and negotiate contracts.
- People Management: Recruit, develop, and maintain staff competence, train personnel, and build motivation within the Quality Assurance team.
- Problem-Solving: Investigate system problems, recommend solutions, and implement changes to ensure compliance and efficiency.
- Change Control: Establish and operate a change control system to ensure compliance for facility, equipment, processes, and acceptance limits.
- Toll Manufacturing: Handle quality affairs for toll manufacturing operations.
- Laboratory Operations: Control laboratory operations for the Micronutrient laboratory.
- R&D: Develop new products, including registration dossiers, material selection, recipe development, trials preparation, and stability studies.
- Recipe Execution: Execute new recipes at the plant for bulk production.
- Formulation Development: Modify and maintain existing formulations regarding quality issues and economical aspects.
- Pesticide Formulations: Formulate new products for different dosage forms of pesticides.
- Monitoring: Monitor all activities related to new recipe development for micronutrient products.
- Analytical Method Development: Develop analytical methods for raw materials, in-process, and finished products.
- Packaging Material Specification: Specify packaging material for all packaging components.
- Training: Provide training for QA and plant staff.
- Certification: Ensure implementation of international certifications like ISO 9001:2008, 17025, 14000, OHSAS, EPA, and others.
- Compliance: Ensure compliance with QMS, GMP, and regulatory audits.
The ideal candidate should possess strong leadership skills, strategic thinking, and a deep understanding of regulatory requirements.
A bachelor's degree in a related field is required. Relevant experience in quality assurance, regulatory compliance, or a related field is an asset.
Benefits:We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
Others:Please submit your resume and cover letter to apply for this exciting opportunity.
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