Job Description

Preparation and review the system based SOP`s. Preparation, Evaluation and closer of change controls, CAPA, Market complaint & deviations Running the plan as per written SOP/WI. Batch entry in ERP (SAP / BAAN) Preparation of the daily production report and commercial report. Compliance with company quality policy in all aspects. Review raw material, intermediate, finished product specifications. Generate, review, and approve GMP documentation such as Standard Operating Procedures, non-conformance reports, Out of specification results. Participate in daily activities, ensuring cleaning, environmental monitoring and maintenance schedules are up to date and maintained to GMP standards. Area and equipment logbooks completed. Implements the manufacturing plan and establishes procedures for maintaining high standards of manufacturing operations to ensure that all products confirm to established customer and company quality standards. Sound Knowledge in Equipment qualification & Process Validation Safety of man and machine and housekeeping of the plant. Avoiding any abnormality in the plant by frequent checks. Ensure the required quality and safety standards are achieved and maintained with respect to cGMP operating procedures, all cGMP batch manufacturing documentation, area housekeeping in cGMP suites, SHE (Safety, Health & Environment), and compliance with the relevant regulatory (ICH Guidelines/MHRA). Training and development of team members. To implement ISO 9001, ISO-14001, SMS -45001, TPM. To implement 5S+1S in plant and office. Qualification & Experience B. Tech (Chemical Engineering) with 3-5 years or B.Sc. (Organic) with 6-7 of experience in Fine Chemical/ Bulk drug / API Plant. Key Competencies ( Technical, Functional & Behavioral) Knowledge of Fine Chemical/ batch chemical process. Practical experience in handling reactors, centrifuges, filters used in API / Bulk drug / Batch chemical plants. Exposure in ERP or like software. Computer proficiency Technical knowledge.