Director of Packaging in Bristol, Tennessee at Gregory Pharmaceutical Holdings Inc

Job Title: Director of Packaging

Reports To: Vice President of Manufacturing and Packaging

Department: Manufacturing

Location: Bristol

Summary: Directs, organizes, coordinates and monitors the activities of the packaging operations in accordance with SOPs, approved batch records, and cGMP procedures.

Essential Duties and Responsibilities:

Management

• Responsible for Packaging Department and personnel at the Bristol location
• Supports company objectives and goals as identified by Senior Management.

Packaging

• Reviews the production plans in the packaging area and manages resource requirements (personnel, facility and equipment) as necessary to meet the planned schedule. Communicates the schedule to other departments.
• Work with supervisory staff to meet the plan requirements and allocation of resources (personnel/shifts/OT/equipment/rooms/etc.) to support packaging requirements as necessary. Responsible for timely execution of activities and performance of staff. Ensures assigned personnel are trained on appropriate procedures / processes for operations, safety, and compliance.
• Reviews and edits master packaging batch records as well as development protocols and necessary forms for use in packaging operations. Reviews and approves documentation produced as a result of packaging operations for conformity with cGMP, and company SOPs and quality policies.
• Manage and continually review the OJT training program for different packaging activities to ensure all packaging personnel are trained on the appropriate equipment/process prior to scheduling staff for each production process.
• Participates in the hiring, performance reviews, and disciplinary actions of all employees working in responsible department.
• Reviews critical processes and equipment for adequate validation documentation and assists the validation activities by reviewing protocols, and implementing qualification activities.
• Prepares and reviews Standard Operating Procedures to address critical packaging steps, equipment set-up procedures, equipment and area cleaning procedures, and equipment operating procedures. Facility SOP's for completeness and effectiveness.
• Trains or retrains technicians in the proper performance of assigned duties in accordance with SOPs, cGMPs, Safety and all company regulations.
• Creates, investigates, participates in, and writes investigations.

Equipment / Facilities

• Reviews, recommends, and monitors appropriate equipment, facility, and technical requirements for the department.
• Performs Routine Walkthroughs of the area to ensure cGMP compliance is properly maintained and provide feedback to the area manager
• Assists with internal audits and area walkthroughs to ensure the facility is audit ready at all times
• Implement site initiatives as it relates to Cleaning and Room Inspection Improvements

General

• Participates in client visits and provides feedback on client contracts concerning scope of work and costs.
• Tracks and trends performance and quality metrics for the packaging department.
• Evaluate Change Controls and drive associated packaging activities to ensure timely implementation and closure.
• Manage CAPAs for the packaging departments and drive to closure.
• Identifies, defines and implements process improvements as part of multi-disciplinary teams for packaging.
• Performs other duties as assigned

Knowledge Necessary to Perform the Job:

1. Extensive knowledge of cGMP practices is essential.
2. Extensive knowledge of company packaging SOPs is essential.
3. Extensive knowledge of operation of technical equipment is essential.
4. Extensive knowledge of processes related to the production of solid dose and semi-solid pharmaceutical manufacturing.
5. Knowledge of FDA, DEA and OSHA regulations as they relate to packaging operations is essential.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Problem Solving - Ability to troubleshoot technical and managerial issues (personnel / production scheduling / etc.) and provide satisfactory resolution in a timely manner.

Planning – Ability to plan multiple operations for both short and long term activities to reflect various resources needs (personnel / equipment / materials) and to address any necessary requirements to attain the production plan. Ability to proactively determine potential issues and to prepare contingency actions to address.

Technical Skills - Familiar with information systems and technologically advanced processes which support the manufacturing of pharmaceutical products. Knowledge of and ability to operate solid dose packaging equipment including, but not limited to product fillers, cappers, lablers, full aggregation process, and secondary cartoning. Advanced knowledge of solid dose and semi – solid pharmaceutical packaging processes required.

Analytical – Collects and researches data using knowledge of all current cGMPs, OSHA and DEA standards and compliance with company SOPs. Gathers and analyzes information skillfully to effectively manage multiple projects and make accurate and effective decisions.

Team Work - Works to effectively and cooperatively communicate the department’s needs and priorities with the rest of the company’s management team.

Written Communication - Writes clearly and informatively. Presents numerical data effectively.

Ethics/Professionalism - Works with integrity and ethically, maintains confidentiality. Interfaces with management and non-management employees in quality, manufacturing, research and development, laboratory services, third party vendors and consultants, and government agencies as required.

Organizational Support - Follows policies and procedures.

Adaptability - Ability to deal with frequent changes to schedules, delays, or unexpected events.

Initiative - Proactively identifies and resolves issues which have the potential to affect manufacturing operations or schedules.

Quality - Observes company quality policies and procedures.

Safety and Security - Observes safety and security procedures.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience: Bachelor’s Degree in Business, Engineering or Science and a minimum of 10 years related management experience, including management of personnel in the pharmaceutical or medical device industry; or equivalent combination of education and experience.

Language Ability: Ability to read, analyze, and interpret common scientific journals, financial reports, and legal documents; respond to inquiries or complaints from customers, regulatory agencies, or members of the business community; effectively present information to top management.

Math Ability: Ability to work with advanced mathematical concepts; apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions; ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.

Computer Skills: To perform this job successfully, an individual should have knowledge of Word, Excel, Access, Microsoft Outlook, and Blue Mountain Preventative Maintenance programs.

Supervisory Responsibilities: Directly responsible for the supervision of employees in manufacturing as well as the manufacturing area and equipment. Includes proper training and staffing of personnel to perform manufacturing activities and in communicating job assignments, work schedules, and performance expectations. Area and equipment for manufacturing would include availability, cleaning, maintenance, calibration, and qualification for use in production activities.

Work Environment and Physical Demands:

The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand, walk, sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must occasionally work around equipment with moving parts. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include ability to adjust focus and distinguish color.