Purpose of this job is to co-ordinate and organize API manufacturing activities
in shifts adhering to cGMP / HSE norms/ standards with optimum utilization of
man / machines and facilities in compliance with regulatory requirements, living
Group’s Values.
Educational qualification/Experience
* M. Sc. (Organic / Industrial Chemistry) or B. Sc. (Tech) or B.E. Chemical
* 1 – 5 year experience of API Plant
Technical skills &
Competencies / Language
* Knowledge of current plant processes and technological updates.
* Knowledge of Production data generation and analysis
* Awareness of Basic cGMP, regulatory and HSE requirements
* Sense of urgency , Maturity, Pro activeness
* Communication , Presentation and Interpersonal skills
* Coordination
* Influencing and decision-making
KEY ACCOUNTABILITIES
Specific
Preparing Standard Operating Procedure (SOP) on operations related to the
manufacturing process as per MFR, BMR and ECR, Equipment Qualification(IQ /
OQ/PQ )documents etc.
Assess,
rationalize and Initiate change control requirement for manufacturing
related modifications, current projects, new proposals.
Ensure necessary investigation and corrective/ preventive actions for deviations
occurring during manufacturing activities.
Preparing and executing the required documents for plant shut down and plant
start up as per available SOP.
Organizing and allocating manpower in shift, based on present strength and
process requirement and priority to ensure planned output and productivity.
Supervising / ensuring performance of activities as per the SOPs, adhering to
GMP /HSE guidelines and also ensuring completeness of BMR and all cross
reference documents in all respects to maintain on line and audit readiness.
Imparting on the job and classroom training to subordinates on SOP / GMP / HSE /
Process / Energy conservation and revised documents.
Ensuring adherence to Quality & HSE systems in the area under
📌 Executive - Production (Chemistry) (Ankleshwar)
🏢 Zentiva
📍 Ankleshwar
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