Manager, Parenteral Inspection and Packaging

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Manager, Parenteral Inspection and Packaging
Location: Manatí PR

Shift: 2nd Shift (12 hrs. rotational 5:00 pm – 5:00 am)

1. Oversees resources availability (material, equipment, personnel – regular and lease workers) necessary to meet and comply with timely production plan.

2. Verifies adherence to procedures and controls and provides corrective feedback during operations by frequent monitoring of production activities.

3. Provides the necessary technical and regulatory documentation direction, support and advice to the Inspection/Packaging Manager in terms of outstanding events or issues on a daily basis; including facilitating the necessary information related to support the packaging processes and fast‑tracking for documenting and implementing process modifications.

4. Ensures budget objectives and productivity or process/line defects are on targets.

5. Drives area projects to completion.

6. Plans work schedules, sets priorities with urgency, keeps work pace, and meets deadlines within a complex, rapidly changing environment.

7. Performs systematic walkthroughs of operation floors.

8. Establishes corrective actions plan to eliminate process deviations and documentation errors.

9. Supports efforts to release lots on hold and conducts thorough reviews of investigation reports. Prepares and/or approves necessary SOPs and forms to be in full compliance with cGMPs and reflect inspection and packaging processes.

10. Monitors scrap factor, equipment downtime, and labor utilization on a regular basis for effective and efficient production plan execution.

11. Identifies opportunities to improve process performance and/or safety requirements and supports Continuous Improvement initiatives in the daily operation activities and other assignments based on business needs.

12. Generates and approves changes as per the established Change Control procedure.

13. Executes supervision role in the area, including but not limited to: defines job skill requirements for the inspection and packaging positions which includes backup operators for critical positions; supports the training program design assuring adherence to training plans including employee certification and re‑certification programs; conducts on‑time personnel performance appraisals, manages vacation schedules, approves payroll administration, and handles disciplinary actions as per Company Policies.

14. Performs as the backup person of the area Manager as required.

15. Supports Maintenance Program by assuring on‑time execution of applicable preventive and corrective maintenance plans.

• Bachelor’s degree in science, administration, or engineering.
• Five years of experience in inspection and packaging for sterile operations processes, including liquid and lyophilized vials and prefilled syringes within a pharmaceutical environment or medical device industry.
• Three years of solid supervisory experience (evaluating, disciplinary actions, performance appraisals, developing succession planning, etc.) or leading multidisciplinary teams.
• Knowledge of product transfer validation within a pharmaceutical environment.
• Ability to facilitate continuous innovation initiatives, foster team building and simplify processes.
• Ability to maintain good employee relations…