Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs. They specialize in unit dose manufacturing and our expertise includes an extensive range of unit dose packaging, such as Blow-fill-seal (BFS). In addition, we also manufacture preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries.
JOB SUMMARY:
Directs and oversees the production process operations. Ensures that all phases of production activity are performed in a safe manner and in compliance with GMP and Standard Operating Procedures (SOP's). Maintains a management presence in the production areas through the monitoring and control of Production processes. Improves the efficiency of the operation by analyzing and correcting production problems; and coordinating with other departments to ensure scheduling efficiency and batch record audit completion.
Team That Consistently Delivers:

• Provides supervision and direction to staff and coordinates work flow within the work unit, including distributing work, disseminating information, assigning staff to cover for absences, providing technical assistance, answering questions, and resolving problems. Ensures work is scheduled effectively; and checkpoints and controls are set for monitoring progress.
• Monitors subordinates' attendance. Reviews and approves vacation and leave requests. Authorizes all overtime. Verifies and approves time cards.
• Manages employee performance by clearly defining job responsibilities and standards of performance; providing clear, thorough, timely feedback. Promptly addresses performance problems through corrective action.
• Evaluates and appraises employee's performance and follows-up with proper documentation.
• Investigates and addresses employee complaints and follows up with Manager, and HR as required.
• Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles.
• Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.
• Assists in interviewing and hiring for subordinate staff.
• Understands HR policies and practices and uses them to manage employees.
• Conducts ongoing assessment and training needs identification including maintaining the training / skill matrix for assigned shift. Creates learning opportunities for all staff as part of daily operations.
• Production Schedule Achieved (20%)
• Drives effectiveness and efficiency of department by; leading daily production meetings, reviewing performance of last 8-24 hours and coordinating with groups outside the Manufacturing/Packaging Team to obtain or provide information and/or resources (such as personnel and equipment).
• Drives high levels of customer service levels by executing the production scheduleanticipating and mitigating operational issues through effective planning and communication with management, staff, peers, and support groups including actively communicating corporate, department, and shift to shift information.

Resources Effectively Deployed:

• Identifies weekly labor requirements and develops a schedule in conjunction with the Manager. Actively participates in covering openings based on unexpected absences and break schedules, etc.
• Coordinates activities with the other shifts according to Production requirements, established priorities and availability of materials for production.
• Develops and maintains the departmental cross functional training matrix to support production and fill in for vacancies as needed through minimal use of overtime.
• Actively manages (minimize) overtime needed to accomplish schedule.

GMP/HS&E Compliance & Process Improvements:

• Participates in Safety/GMP Audit Programs.
• Will halt process and immediately notify QA and Manager of any concerns for Product Safety or quality.
• Participates in investigations and prepares PR/Audit documentation as appropriate.
• Ensures stakeholders are appropriately trained on the process and any process changes.
• Identifies and implements opportunities for improvement in GMP, compliance, waste reduction, streamlining processes, etc. while maintaining process effectiveness (e.g. 5S).
• Evaluates effectiveness of SOPs, identifies changes that would enhance processes, and ensures that all change control documentation is implemented.
• Reviews, edits, and approves Operations documents.

Clean & Safe Work Environment

• Monitors Production area conditions and ensures that work areas are organized, free from hazards, and that the Production floor is clean.
• Monitors and verifies that all assigned employees, including temporary labor, follow company GMPs, safety regulations, and all general workplace SOPs and practices. Addresses any observed violations and notifies Manager.
• Holds regular safety meetings.

QUALIFICATIONS/EXPERIENCE:

• B.S. degree strongly preferred with 2 years related experience preferably in a pharmaceutical or regulated environment; or
• Associate's degree with 5 years related experience preferably in a pharmaceutical or regulated environment
• Two (2) years of supervisory experience preferred
• SPECIFIC SKILLS:
• Ability to lead and maintain adequate level of performance of individuals engaged in job tasks that are highly structured, routine, and repetitive.
• Ability to resolve problems and issues to ensure efficient flow of manufacturing operations and work completion.
• Basic math skills and ability to understand the metric system required.

Job Requirements