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

To prepare BMR/BPR/ECR/SOPs and to review completed BMR/BPR/ECRs.
To co-ordinate QMS related activities (i.e., process validation, cleaning validation, deviation, change control), market complaint, OOS/OOT, product recall related activities.
To ensure equipment/instrument calibration and preventive maintenance is as per schedule.
To maintain cGMP and safety norms in plant & to ensure that activities are being performed as per relevant SOP.
To distribute manpower as per requirement in manufacturing area & to plan and execute activities as per the schedule with optimum utilization of plant capacity.
To be well versed with GMP & ICHQ7.To give training to plant personnel on SOPs & documentations.
To co-ordinate with Engineer/QC/QA.
Handling Material Management

QUALIFICATIONS & EXPERIENCE

Degree in Chemical Engineering.
5 - 8 years of relevant experience in production, preferably within chemical synthesis or the pharmaceutical industry.

MANAGERIAL COMPETENCIES

Manpower coordination and work planning
Training and communication
Cross-functional coordination
Accountability and compliance mindset

TECHNICAL COMPETENCIES

BMR/BPR/ECR/SOP preparation and review
QMS activities including validation, deviation and change control
Equipment calibration and preventive maintenance coordination
cGMP and ICH Q7 requirements
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.

Production Executive At Emzor Pharmaceutical Industries Limited

Key skills

At a glance