Assistant Manager
1 week ago
KEY RESPONSIBILITIES
Production Management
:
- Oversee and manage day-to-day production operations to meet quality, cost, and delivery
targets.
- Develop and implement production schedules to ensure the 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
Educational Qualifications
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Chemistry, Biotechnology, or a related field.
- Minimum of
5-14 experience in pharmaceutical manufacturing in a managerial role
. - Proven experience working in a USFDA-regulated environment, with knowledge of cGMP, CAPA, and regulatory submissions.
Technical / Functional 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.
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