About this role
ROLE SUMMARY
To support day-to-day production activities in the Crude and PP areas, including production documentation, QMS activities, equipment readiness, cGMP and safety compliance, manpower coordination and material management.
KEY RESPONSIBILITIES
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To prepare BMR/BPR/ECR/SOPs and to review completed BMR/BPR/ECRs.
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To co-ordinate QMS related activities (i.e., process validation, cleaning validation, deviation, change control), market complaint, OOS/OOT, product recall related activities.
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To ensure equipment/instrument calibration and preventive maintenance is as per schedule.
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To maintain cGMP and safety norms in plant & to ensure that activities are being performed as per relevant SOP.
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To distribute manpower as per requirement in manufacturing area & to plan and execute activities as per the schedule with optimum utilization of plant capacity.
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To be well versed with GMP & ICHQ7.To give training to plant personnel on SOPs & documentations.
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To co-ordinate with Engineer/QC/QA.
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Handling Material Management
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QUALIFICATIONS & EXPERIENCE
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Degree in Chemical Engineering or related field.
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5–8 years of relevant experience in production, preferably within chemical synthesis or the pharmaceutical industry.
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MANAGERIAL COMPETENCIES
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Manpower coordination and work planning
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Training and communication
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Cross-functional coordination
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Accountability and compliance mindset
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TECHNICAL COMPETENCIES
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BMR/BPR/ECR/SOP preparation and review
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QMS activities including validation, deviation and change control
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Equipment calibration and preventive maintenance coordination
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cGMP and ICH Q7 requirements
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Material management
WHAT WE OFFER
- Competitive salary and performance-based bonuses.
- A supportive and dynamic work environment with clear career growth opportunities.
- Comprehensive medical insurance, pension, and other employee benefits.