Responsible for coordinating the Parenteral Inspection and Packaging operation efficiencies, labor utilization and expenses in the shift assuring compliance with applicable policies, regulations, and procedures. The incumbent must comply with Corporate and HR Policies and; FDA, GMP, Environmental Health and Safety goals program, objective and regulations and; with current Good Manufacturing Practices required by the job function.
Oversees resources availability (material, equipment, personnel regular and lease workers) necessary to meet and comply with timely production plan.
Verifies adherence to procedures and controls and, provides corrective feedback during operations by frequent monitoring of production activities.
Provides the necessary technical and regulatory documentation direction, support and advice to the Inspection/Packaging Manager in terms of outstanding events or issues on daily basis; including to facilitate the necessary information related to support the packaging processes and fast tracking for documenting and implementing process modifications.
Ensures budget objectives and productivity or process/line defects are on targets. Drives area projects to completion.
Plans work schedules, set priorities with urgency, keeps work pace, and meet deadlines within a complex, rapidly changing environment. Performs systematic walkthroughs of operation floors.
Establishes corrective actions plan to eliminate process deviations and documentation errors.
Supports efforts to release lots on hold and conducts thorough reviews of investigation reports.
Prepares and/or approves necessary SOP's and forms to be in full compliance with cGMP's and reflect inspection and packaging processes.
Monitors scrap factor, equipment downtime, and labor utilization on a regular basis for effective and efficient production plan execution Identifies opportunities to improve process performance and / or safety requirements and supports Continuous Improvement initiatives in the daily operation activities and any other assignments based on business needs.
Generates and approve changes as per the established Change Control procedure.
Executes supervision role in the area including but not limited to: defines job skill requirement for the inspection and packaging positions which includes back up operators for critical positions and supports the training program design assuring adherence to training plan including employee certification and re-certification program; on time personnel performance appraisals, vacation schedules and approval, attendance (Kronos) administration for payroll processing, personnel leave of absences administration and standard development, etc.; manage disciplinary actions when necessary as per Company Policies, monitoring of attendance trends enforcing applicable Company policies and procedures, promotes and models BMS Core Behaviors, facilitates teamwork, provides coaching and feedback etc.
Performs as the back up person of the area Manager as required.
Supports Maintenance Program by assuring on time execution of applicable preventive and corrective maintenance plans.
Bachelor Degree in Science, Administration, or Engineering
Five (5) years of experience in inspection and packaging for sterile operations processes, including liquid and lyophilized vials and pre filled syringes within pharmaceutical environment or within a medical device industry.
Three (3) years of solid (evaluating, disciplinary actions, performance appraisals, developing succession planning, etc) supervisory experience, or leading multidisciplinary teams.
Knowledge in product transfer validation within Pharmaceutical environment.
Ability to facilitate continuous innovation initiatives, foster team building and simplify processes.
Ability to maintain good employee relations and to handle grievances and complaints.
Self-starter with strong leadership characteristics, analytical, administrative and people skills.
Ability to communicate and work effectively in a team oriented environment.
Knowledge of cGMPs, safety and environmental regulations, human resources and labor laws.
Personal computer skills, knowledge in Excel, Word, PowerPoint, Internet.
Fully bilingual oral and written (Spanish/English). Technical writing skills.
Sense of urgency and business needs.
Capability to use protective gowning
Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.
Bristol Myers Squibb