Job Description
- Oversee and manage day-to-day production operations to meet quality, cost, and delivery targets.
- Develop and implement production schedules to ensure timely delivery of products.
- Ensure adherence to Good Manufacturing Practices (GMP) and compliance with USFDA regulations.
Regulatory Compliance:
- Maintain and ensure compliance with USFDA, WHO, and other regulatory standards in all production processes.
- Coordinate with the Quality Assurance (QA) team to prepare for and manage regulatory audits and inspections.
- Ensure proper documentation of all manufacturing processes as per USFDA requirements.
Team Leadership:
- Lead, mentor, and train the production team to ensure optimal performance and awareness of regulatory requirements.
- Foster a culture of continuous improvement, accountability, and teamwork.
Process Improvement:
- Identify and implement process optimizations to improve productivity, efficiency, and quality.
- Collaborate with cross-functional teams such as R&D, Quality Control (QC), and Supply Chain to resolve production-related issues.
Equipment and Facility Management:
- Ensure proper maintenance and calibration of production equipment and facilities.
- Implement safety protocols to maintain a hazard-free work environment.
Resource Planning:
- Manage inventory of raw materials and ensure uninterrupted production.
- Prepare and manage the production budget to optimize costs without compromising quality.
KEY SKILLS:
- Strong understanding of pharmaceutical production processes, including tablet, capsule, injectable, or API manufacturing.
- Familiarity with validation protocols, including IQ, OQ, and PQ processes.
- Exceptional leadership, communication, and interpersonal skills.
- Strong analytical, problem-solving, and decision-making abilities.
- Ability to work under pressure and meet tight deadlines.
QUALIFICATION: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or a related field.
EXPERIENCE: 5-7 years