What are the responsibilities and job description for the QC Supervisor position at Piramal Enterprises?
Business: Critical Care
Department: Quality Control
Location: Bethlehem, PA
Job Overview
Responsible for all Quality Control functions of Bethlehem.
Ensure PCC Bethlehem Quality Control department is performing in line with our core values & ethical practices.
Ensure that the customer (internal and external) needs are understood properly, and the services / products are delivered on time in full, from Quality Control function perspective.
Key Stakeholders: Internal
API Manufacturing, Packaging, Quality Assurance, Engineering, Regulatory Affairs, EHS, Supply Chain and Logistics
Key Stakeholders: External
Auditor, Customers, Regulatory Agencies, External Suppliers
Reporting Structure
Directly reports to Senior Manager of Quality Control
Essential Duties and Responsibilities
- Lead the QC Analysts in daily operational workflow by efficient allocation of resources.
- Perform a wide variety of activities to establish and ensure compliance with quality systems, quality procedures and policies and regulatory requirements to facilitate compliance with the agencies and customers.
- Develop, implement, and maintain programs and processes to ensure high quality products and compliance with IHC, cGMP, GLPs and a safe & clean lab operation.
- Responsible for the maintenance of QC Lab documentation SOP’s, methodology, specifications, calibrations sheets, logbooks, etc. through change control.
- Lead or participate in focused deviation cross-functional investigations, improvement projects and other initiatives.
- Review and approve QC Lab’s GMP test and lab operational documents.
- Perform the role of QC Lab Representative in coordinating, deviations, investigating and assessing Change Control Requests (CCR’s), as designated within this process.
- Identify Continuous Improvement Opportunities and perform their implementation.
- Implement management’s strategies and activities related to assuring compliance with regulations and ensure the company’s data integrity.
- Provide support for QC operations information during agency inspections as requested by Quality head.
- Manage all quality processes through SAP inventory management system.
- Batch production & in process samples testing record review and approval for release.
- Retains & Stability testing program oversight.
- Incoming Raw Materials and labeling materials approval.
- Quality systems support, including but not limited to: Investigation Support, Labeling, complaints, document control, training, CAPAs & Annual Product Reviews.
- Participates in product development support, including but not limited to: Methodology Transfers, Stability program, project management, and oversight of special studies supporting regulatory filings, data/record retrieval for regulatory submissions.
- Prepare protocols, reports, metrics trend reporting, validation, logs & other documentation as needed.
- Maintains all QC Lab equipment in proper operational state, calibrated and qualified to include the equipment operating software packages.
- Other quality activities in support of the product as necessary & agreed upon.
Key Competencies (knowledge, skills, and abilities every person must possess to be successful)
- Well-organized and detailed oriented professional, with strong verbal and written communication skills
- Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
- Creative and able to present various solutions
- Energetic, enthusiastic, and motivational disposition
- Maintain confidentiality
- Coaching skills - Ability to lead and develop Quality team at the site
- Proficiency with computer office tools (Word, Excel, Outlook & scientific databases, etc.) is required.
- Ability to lead the QC Analysts in a fast-paced environment, manage priorities & maintain timelines for multiple projects is essential.
Education / Experience
- B.S. in Chemistry or related discipline is required.
- Minimum 5 years’ experience working in a pharmaceutical manufacturing laboratory environment.
- Minimum 3 years of supervisory experience in a pharmaceutical manufacturing laboratory environment.
- Lab testing in an environmentally controlled manufacturing facility.
- Hands-on experience of quality systems in a GxP environment, and direct experience with FDA, MHRA and other health authority inspections
- Good experience of handling DI breaches and awareness of requirements
- Good knowledge of international regulations & audit experience a plus.