
Regulatory Compliance Specialist
5 days ago
Job Description
- Responsible for regulatory requirements and their interpretation, including Current Good Manufacturing Practices, Good Laboratory practices, and Equipment purchase, calibration, repair, and Maintenance.
- Responsible for Quality Planning, Organizing, Directing, Controlling, and Evaluating activities related to Quality.
- Responsible for Quality Operations, Budgeting, Goal Setting of Quality Assurance Department.
- Responsible for Consultation and negotiation with equipment vendors and suppliers to prepare specifications, explain proposals, and present Quality Reports and findings.
- Responsible for assigning, coordinating, and reviewing Technical Work of the Department or project team.
- Responsible for Recruiting Personnel, Development, and maintenance of staff competence in required areas, Training, and accomplishment of Technical Resources with a proven record in building and motivation of Quality Assurance Efforts.
- Able to accomplish staff results by communicating job expectations, planning, monitoring, and appraising job results, coaching, counseling, and disciplining staff, developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
- Responsible for Investigating system problems to recommend and implement solutions.
- Able to establish and operate change control system to ensure compliance for the facility, equipment, processes, and acceptance limits.
- Responsible for handling Quality Affairs of Toll Manufacturing.
- Responsible for controlling laboratory operations of the Micronutrient laboratory.
- Responsible for Research and Development of new products comprising Registration dossier, Material selections (Local and Import), Recipe Development, Trials preparation, and stability studies.
- Responsible for executing New Developed recipes at plant for Bulk Production.
- Responsible for Modification and maintenance of existing formulations regarding Quality Issues and economical aspects.
- Responsible for Formulations of new products for different dosage forms of Pesticides, Especially EC, EW, OD, FS, SC, WP, WDG, WSG, WS, SP, SE, CF, and SL etc.
- Monitoring of all activities regarding new recipe development micronutrient products.
- Responsible for Development of analytical methods of Raw Materials, In-process, and finished Products.
- Responsible for Packaging Material Specification of all packaging components.
- Responsible for Trainings of QA and plant staff.
- Should have strong knowledge and implementation skill as MR of International certification like ISO 9001:2008, 17025, 14000, OHSAS, EPA, and others.
- Responsible for the compliance of QMS, GMP, and Regulatory audits.
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