Position Summary

The Manager of Quality Control manages visual inspection and compliance in the production of high quality packaging components for the parenteral pharmaceutical market.  Designs and implements inspection processes and standard operating procedures (SOPs) that incorporate the International Organization for Standardization’s ISO certification and other Quality System requirements, along with current Good Manufacturing principles and practices (cGMPs). 

Supervises staff, modeling the Datwyler Sealing Solutions philosophy.   Provides the best possible safeguards against hazards and accidents, and ensures that established procedures are followed.  Monitors and adjusts Quality operations to meet goals and objectives; leads staff on tasks completion and provides ongoing developmental opportunities. 

Essential Functions

• Organize and supervise quality control analytical, physical testing, and microbiological functions, including incoming material testing and release, in-process testing, finished product testing, water testing and environmental control
• Knowledgeable to serve as back up for in process and finished product testing as needed
• Responsible for respecting lead-times and schedules as agreed upon with Supply/Logistics
• Organize, supervise and conduct: non-conforming document approval/batch disposition and quality approval of deviations/OOSs
• Responsible for disposition of raw materials, intermediates and finished goods
• Knowledgeable of change control management.
• Provide approval of Qualification/Validation Documents, as needed.
• Develop, revise, review, and implement Standard Operating Procedures and Work Instructions for QC functions or other department’s final approval
• Conduct training as needed to ensure compliance with cGMPs

Essential Functions Continued

• Play active role in problem-solving initiatives to address customer or regulatory quality issues.  Actively drive efforts to determine and implement corrective and preventive actions; report quality issues and trends.
• Define and follow-up of maintenance and calibration of lab equipment
• Develop and maintain quality metrics, statistics and records for QC performance
• Develop & coach QC department employees in order to align capacity and capability with business needs
• Serve as the Quality Control representative to the Management Review Meetings and participate in Quality Review Meetings, as needed
• Participate in GMP audits (customer, supplier and internal audits), ISO audits (9001 and 15378),  and other regulatory agencies.
• Review, approve, and maintain customer specifications.
• Manage inspection plans and COA profiles to align with requirements.
• Responsible for training and development of the QC  team
• Ensuring department’s compliance with all safety rules and procedures, as well as good housekeeping within the plant, in accordance with SOPs, Work Instructions, and cGMPs.

Your Profile - Education and Experience

• Bachelor’s degree in science, chemistry, microbiology or equivalent
• Minimum of 5 years’ experience in Quality Management positions, preferably working in a Pharmaceutical Manufacturing Plant environment
• Must have knowledge of cGMPs (FDA and EU) and ISO standards

Skills and Abilities

• Minimum of five (5) years in a QA/QC position, specifically in a pharmaceutical or packaging component industry (or closely related industry)
• Thorough knowledge of cGMP regulations and current industry practice
• Thorough knowledge of quality control (chemical, microbiological, visual inspection)
• Knowledge of ISO 9001 and 15378 and Continuous Improvement Tools
• Good organizational and planning skills
• Provides team with a clear sense of direction, inspires and co-ordinates others and keeps them focused on objectives, including coaching and self-development
• Adheres to company rules and procedures. Executes plans with commitment and determination. Achieves high quality results.
• Quickly understands and analyzes complex issues and problems. Comes up with sound and rational judgments. Demonstrated analytical skills, problem-solving skills, statistical and mathematical abilities and interpersonal skills.
• Communicates in a clear, precise and structured way. Excellent communication skills in English (written and verbal). Speaks with authority and conviction. Presents effectively.
• Strong computer skills including Quality applications, word processing, spreadsheets and databases