Key Responsibilities:

- Manage toll manufacturing partnerships by working closely with third-party manufacturers to ensure adherence to production schedules, quality standards, and company specifications.

- Oversee quality assurance processes at toll manufacturing sites, ensuring compliance with internal quality control measures and regulatory standards, including GMP, FDA, and ISO.

- Monitor and inspect product quality throughout the production lifecycle, from raw material receipt to final product release, ensuring that all products meet established specifications.

- Conduct regular quality audits at toll manufacturing facilities to assess compliance with company standards, identify areas for improvement, and implement corrective and preventive actions (CAPA).

- Collaborate with the internal Quality Assurance (QA) team to establish and maintain quality management systems (QMS), including standard operating procedures

- Work with cross-functional teams, including supply chain, procurement, and R&D, to ensure that toll manufacturing processes are aligned with overall production goals and timelines.

- Drive continuous improvement initiatives to enhance production efficiency, reduce costs, and improve product quality across toll manufacturing partners.

- Ensure compliance with regulatory requirements, such as FDA, ISO 9001, and other relevant industry standards, throughout the toll manufacturing process.

- Investigate quality issues and deviations, working with toll manufacturers to resolve non-conformances and implement corrective actions to prevent recurrence.

- Maintain communication with toll manufacturing partners to address quality concerns, production issues, and any other operational challenges that may arise.

- Report on key performance indicators (KPIs) related to toll manufacturing, including production output, quality metrics, lead times, and cost-effectiveness.

- Ensure documentation accuracy, including batch records, certificates of analysis (CoAs), and other quality-related documents, to maintain traceability and compliance.

Required Qualifications:

• Bachelor’s degree in Engineering, Chemistry, Quality Management, or a related field.

• Minimum of 3-5 years of experience in toll manufacturing, with a strong focus on Quality Assurance/Quality Control (QA/QC).

• Proven experience with GMP, ISO, and FDA regulations and their application in a manufacturing environment.

• Strong understanding of quality management systems (QMS), SOPs, and quality control processes.

• Excellent problem-solving skills, with the ability to identify root causes of quality issues and implement effective corrective actions.

• Strong project management skills, with the ability to manage multiple toll manufacturing relationships and meet tight production deadlines.

• Proficiency with ERP systems and other digital tools used for quality management and production tracking.

• Strong communication and interpersonal skills to effectively manage third-party relationships and cross-functional collaboration.

Interested candidates should submit their resumes, at [Click to show email] or WhatsApp:01061484830 Please mention “Toll ” in the subject.