
Quality Control and Assurance Lead
5 days ago
The Director of Compliance and Regulatory Affairs is responsible for overseeing regulatory requirements and ensuring compliance with industry standards. This includes developing quality plans, coordinating activities related to quality operations, and overseeing the Quality Assurance Department.
Key Accountabilities:
- Ensure compliance with regulatory requirements, including GMP, GLP, and ISO 9001:2008.
- Develop and implement quality planning, organizing, directing, controlling, and evaluating activities related to quality operations.
- Oversee quality operations, budgeting, and goal setting for the Quality Assurance Department.
- Collaborate with equipment vendors and suppliers to prepare specifications, explain proposals, and present quality reports and findings.
- Assign, coordinate, and review technical work of the department or project team.
- Recruit personnel, develop staff competence in required areas, and accomplish technical resources with a proven record in building and motivating quality assurance efforts.
- Improve staff results by communicating job expectations, planning, monitoring, and appraising job results, coaching, counseling, and disciplining staff, developing and enforcing systems, policies, procedures, and productivity standards.
- Investigate system problems to recommend and implement solutions.
- Establish and operate a change control system to ensure compliance for the facility, equipment, processes, and acceptance limits.
- Handle quality affairs of toll manufacturing.
- Control laboratory operations of the micronutrient laboratory.
- Research and develop new products comprising registration dossiers, material selections, recipe development, trials preparation, and stability studies.
- Execute new developed recipes at the plant for bulk production.
- Modify and maintain existing formulations regarding quality issues and economical aspects.
- Formulate new products for different dosage forms of pesticides.
- Monitor activities regarding new recipe development of micronutrient products.
- Develop analytical methods for raw materials, in-process, and finished products.
- Responsible for packaging material specification of all packaging components.
- Train QA and plant staff.
- Implement strong knowledge and skills for international certifications like ISO 9001:2008, 17025, 14000, OHSAS, EPA, and others.
- Ensure compliance of QMS, GMP, and regulatory audits.
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