Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office
Job Description
Scope of the Position / Responsibilities:
Ensure the achievement of production objectives of the assigned department in terms of quantity, timing, costs, and quality through directing, coordinating, training, and controlling the staff structure, contributing to the creation of operational instructions, verifying compliance with master batch records, coordinating with other departments, respecting budget, customer needs, GMP, company procedures, quality standards, safety, and environmental regulations.
Primary Activities:
Production Budget
* Support the supervisor in planning and controlling the department’s performance against the budget, including assessing needs for materials and human resources, sharing production goals, analyzing variances, and proposing corrective actions, all while adhering to quality standards.
Production
* Ensure the production of requested pharmaceuticals by directing, coordinating, and controlling the staff, supporting operational instructions, managing anomalies, coordinating with other production departments, and ordering necessary consumables within budget and quality requirements.
Quality
* Guarantee compliance with quality standards by supervising SOPs and procedures, overseeing validations, sample collection, process controls, and ensuring data conformity to GMP before submission to QA.
Procedures
* Work with the Production Manager to keep SOPs and operational procedures up-to-date, verifying documentation and updating as needed in accordance with GMP.
Consumables Management
* Maintain adequate stock levels by defining minimum orders and overseeing the ordering process, respecting budget constraints.
Cost Control
* Assist the Production Manager in monitoring costs, ensuring correct cost allocation and order verification.
Maintenance
* Support Technical Services in maintaining production equipment, overseeing efficiency, reporting issues, and supporting problem resolution within quality and production standards.
Technical Training
* Ensure technical training of staff, assessing needs and proposing appropriate actions within budget.
Sampling Activities
* Oversee chemical and microbiological sampling activities, ensuring proper documentation according to SOPs.
Personnel Management
Lead, coordinate, and control staff, setting objectives, evaluating results, and fostering development to ensure high performance and motivation.
Requirements and Qualifications
Essential:
* Degree in scientific disciplines or diploma
* Knowledge of key machinery for sterile injectable production
* Proficiency in information systems and delegation tools
* Basic microbiology knowledge and GMP awareness related to aseptic processing
Professional Experience:
* Extensive experience operating sterile injectable manufacturing plants
* Experience in personnel management
Languages: English
Personality Traits:
* Leadership
* Team management skills
* Delegation attitude
Desirable:
* Degree in CTF
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