PREP Filling Manager (Vaccines)

Role Responsibilities

Safety:

• Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings

• Reports all safety issues, concerns, incidents and near misses to the team leadership

• Actively participates in safety walkthroughs coordinated by the department’s safety team

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues

Quality:

• Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections

• Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies

• Supports SGS meetings and proactively addresses observations

• Conducts real time reviews to assess aseptic performance, GMP data entries, and all metrics are accurately updated

• Understands the function of the quality group and works with them to maintain a positive rapport.

Delivery:

• Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs.

• Follows escalation procedures to mitigate any variables negatively impacting eOEE.

• Reviews eOEE metrics throughout shift to ensure proper categorization of downtime.

• Ensure training of personnel is assigned and entered as needed in order to support business needs.

• All other duties as assigned. Adheres to all other company time keeping and attendance policies.

Cost:

• Executes procedure as documented to avoid deviations.

• Ensure training methodologies are implemented to improve operator efficiencies.

• Supports all changeover related functions to achieve eOEE standard.

Involvement:

• Works to become trained in all assigned training modules.

• Trains and orients new team members (at any level) as assigned. 

• Participates and leads team meetings.  Understands respect, professionalism and confidentiality.

• Ensures Training coordinator / Trainers, train and guide personnel in proper work procedures, use of equipment, cGMP’s, safe work techniques, and SAP to assure timely signoffs and consistency in training. Maintains qualified trainer status.

Preferred Qualifications

• Must be very detail-oriented and organized with excellent time-management skills

• Strong analytic and problem-solving abilities, as well as the flexibility to change and adapt as the job grows and develops

• Excellent verbal and written communication, interpersonal and presentation skills, as well as the ability to interact tactfully and effectively with employees at all levels of the organizational structure

• Intermediate proficiency in MS Office Suite

• Working knowledge of SAP preferred

• Lean manufacturing preferred

Minimum Requirements

• BS degree in Life Sciences, Engineering or equivalent with relevant experience in manufacturing and/or filling of biological products or 7+ years relevant experience in manufacturing and/or filling of biological products

• 3-5 years' experience in manufacturing and/or development departments

• Must have previous experience in working with a production department of a pharmaceutical company.

• Experience in FDA Regulated Industry

• Working knowledge of cGMP's