JOB SUMMARY:Executive-Production (QMS) shall be responsible to ensure the effective implementation and adherence to Quality Management System (QMS) standards within the production department and assuring that all Production QMS activities are performed in compliance with applicable regulations, company specifications, procedures, and policies and current industry practices.RESPONSIBILITIES:Oversee the implementation and maintenance of QMS standards and procedures within the production formulation department, ensuring compliance with regulatory requirements. Conduct regular QMS audits and internal assessments to identify areas for improvement and ensure compliance. Develop, maintain, and manage QMS documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records. Ensure accurate and timely documentation of all production processes, quality checks, and deviations. Monitor and review production processes to ensure adherence to established quality standards and specifications. Investigate and resolve quality issues and non-conformances promptly. Provide training and education to production formulation staff on QMS requirements, quality control techniques, and regulatory compliance. Promote a culture of quality awareness and continuous improvement within the department. Ensure compliance with all relevant regulatory requirements, including local, national, and international standards. Prepare and submit required regulatory documentation. Participate in root cause analysis and corrective action activities to prevent recurrence of quality issues.SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIESExperience in production formulation processes (Sterile/Injectable/Vaccine formulation). Must be proficient in preparation of documents such as SOP, Gap assessment, risk assessment, BMR, Protocols etc. Must have experience to handle the QMS element i.e. deviation, change control, CAPA, incident etc. Must be able to effectively communicate with large groups and work collaboratively. Excellent verbal and written communication Strong understanding of QMS standards and regulations.
Job Title
SCIENTIFIC OFFICER - PRODUCTION (QMS)