Quality Assurance Supervisor

Business: Piramal Pharma Solutions, Inc.

Department: Quality Assurance

Location: Lexington

Job Overview

The Supervisor Quality Assurance supports the successful manufacturing of parenteral pharmaceutical products by overseeing Quality Assurance Specialists and Sr. Specialists, coordinate QA team activities across shifts on day-to-day basis, and ensuring activities meet all regulatory and internal GMP requirements.

Reporting Structure

Sr. Manager Quality Assurance

Education

• High School education or equivalent required

• Bachelor's Degree in physical or biological sciences or related scientific field preferred

Key Responsibility

• Supervisor Quality Assurance will provide direct oversight of Manufacturing Quality Assurance Specialists and Sr. Specialists team members

• Development of Quality Assurance Specialists and Sr. Specialists. Implementing and tracking training plans, prioritizing and monitoring goals, performing routine one on one meetings, and year end evaluations.

• Collaborates effectively with internal department functions to ensure alignment around production priorities and administrative tasks.

• Daily interaction with Quality Assurance Specialists and Sr. Specialists to assist with troubleshooting, documentation corrections/notes, floor walkthrough and guidance on all day-to-day activities.

• Reviews and Approves master records including Master Calibration Records, Standard Operating Procedures (SOPs), Protocols, Client Specific Records, and other GMP documents.

• Reviews and audits production batch records to ensure adherence to policies, SOPs, and cGMP requirements.

• Reviews all documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures.

• Participates in audits and onsite client interactions as needed by management.

• Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings.

• Supports operations to encourage a Quality Culture and ensure a safe working environment.

• Establishes processes to ensure compliance and improvement to the Quality Management System (QMS), focusing on the following subsystems.

• EVR's

• Corrective and Preventive Actions

• Complaint Handling

• Documentation and Record Controls

• Training

• Risk Management

• Data Integrity

• Perform administrative activities such as timecard approvals and time off requests.

• Executing the responsibilities of line clearances, AQL, and real time record review in the event Quality Assurance Specialists and Sr. Specialists are unavailable.

• Perform other duties as assigned.

Experience

• 5+ years of Quality, performing quality related activities within a pharmaceutical manufacturing environment

• Must have previous experience working within strict regulatory guidelines, cGMP or FDA

• 2+ years' experience leading teams, either formally or informally

Competencies

• Thorough knowledge of cGMP principals and other industry requirements

• Excellent written and verbal communication skills

• Excellent analytical and problem solving skills

• Excellent leadership and team building skills

• Technical writing experience, preferred

• Proficiency with Word, Excel and PowerPoint