Asst Manager / Dy Manager Production

Job Responsibilities

1. Production Planning and Execution:
   
• Receive and evaluate weekly production schedules, ensuring alignment with material availability, machine loading, manpower readiness, and tooling requirements.
• Prepare daily production plans and oversee seamless execution to meet production targets.
2. Material and Resource Management:
   
• Coordinate with the stores team to requisition and receive materials in advance to prevent production delays.
• Verify materials for quality, accuracy, and compliance with requisitions.
3. Process Management and Compliance:
   
• Ensure manufacturing processes align with Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
• Strictly adhere to Standard Operating Procedures (SOPs) and ensure documentation accuracy during all production activities.
4. Quality Assurance and Regulatory Compliance:
   
• Conduct in-process checks to maintain quality standards and process parameters within specified limits.
• Ensure readiness for USFDA, EU, and other regulatory audits by maintaining compliance with cGMP and regulatory requirements.
• Specialize in the production of Oral Solid Dosage (OSD) forms and oncology products for regulated markets.
5. Validation and Technology Transfer:
   
• Lead validation activities, including process, cleaning, equipment, and system validations.
• Facilitate technology transfers from development to production, specifically for OSD and oncology products.
6. Safety and Operational Excellence:
   
• Promote safe working practices and maintain a clean and organized work environment.
• Optimize facility and personnel utilization for enhanced efficiency and output.
7. Team Leadership and Development:
   
• Evaluate team performance, provide constructive feedback, and align them with organizational goals.
• Conduct training sessions through Automated Training & Learning Management Systems or other formats.
8. Audit Management and Documentation:
   
• Act as an internal and external audit auditor/auditee for regulatory and process audits.
• Review and ensure accuracy in executed batch manufacturing and packaging records.
9. Cross-functional Coordination:
   
• Collaborate with the supply chain team for effective production planning.
• Participate in technical discussions and cross-functional improvement initiatives.
10. Additional Responsibilities:
    
• Handle warehouse-related activities during staff absence, including material receipt, dispensing, and monitoring.
• Update systems and processes to align with current industry regulations and standards.

Key Requirements

• Education: Bachelors/Master’s degree in Pharmacy, Engineering, or a related field.
• Experience: Minimum 10 years in pharmaceutical production, with significant exposure to regulated markets (e.g., USFDA, EU).
• Product Expertise: Must have hands-on experience with Oral Solid Dosage (OSD) forms and oncology products for regulated markets.
• Skills:
• Proficiency in SAP/ERP systems.
• Strong leadership, team management, and problem-solving skills.
• Expertise in cGMP, validation activities, and technology transfer.

Preferred Qualifications

• Direct involvement in handling USFDA, EU, or similar regulatory audits.
• Experience in managing process improvements and operational excellence initiatives.

Key Competencies

• High attention to detail and quality standards.
• Ability to thrive under pressure and meet deadlines.
• Strong communication and cross-functional collaboration skills.