
Director of Production Operations
4 days ago
The Head of Manufacturing Position
This role oversees the manufacturing and finishing operations team at a plant in Karachi, Pakistan. Reporting to the operations director, this position is responsible for ensuring compliance with regulatory requirements, cGMP, EHS & quality standards during manufacturing and finishing operations.
Key Responsibilities
- Prepare and monitor operational plans for optimal resource utilization (material, labor, and overheads).
- Ensure products are manufactured under conditions that meet policies, EHS standards, and regulatory and cGMP requirements.
- Ensure compliance with labor laws, security standing orders, and code of business conduct.
- Provide necessary resources (area, equipment, workforce) to produce quality products.
- Ensure initial and continuing training of production personnel, including GMP training, as needed.
- Provide strategic direction in manufacturing technology and equipment, ensure maintenance of premises and equipment, calibrations, and process validation.
- Coordinate with quality regarding QA audits, CAPA, complaints, ERs, market returns, and trend analysis reports.
- Coordinate with QA, regulatory, technical center, engineering, and supply chain to resolve quality problems and ensure uninterrupted product deliveries.
- Take into account demands (forecasts, contracts, customer orders, samples, special prototypes, spares, interplant) to create a master schedule directing all manufacturing, purchasing, and manufacturing-related engineering activities.
- Monitor KPIs and perform root cause analysis where applicable.
- Review and approve technical documents (SOPs, manufacturing directions, shop orders, validation documents, change requests, CAPAs, ERs, etc.).
- Ensure production records are reviewed and signed before being made available to the quality assurance department.
- Review new product dossiers and manufacturing input for product registration/re-registration and submission to the regulatory department.
- Review batch variance/yield reports with production managers and take appropriate steps for improvement.
- Eliminate non-value-added activities, prioritize employee development, goal setting, performance assessment, and succession planning within the department.
- Perform other tasks assigned by the operations director.
Qualifications and Skills
- Bachelor's degree in pharmacy or equivalent.
- 10 years of experience in manufacturing and finishing operations.
- Knowledge of drug rules, cGMP requirements, and quality standards.
- Understanding of supply chain management for multinational companies.
- Awareness of operational finance and capital budgeting.
- Understanding of business excellence and new product development activities.
Required Competencies
- Good communication and interpersonal skills.
- Proven leadership qualities.
- Ability to thrive in a fast-paced environment.
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