Compliance Specialist - QA
Purpose: Using in-depth knowledge of relevant guidance or regulatory documents, perform and lead routine and non-routine compliance activities to include Change Control, Audit management, Gap Assessment, and Regulatory documentation such as Annual Product Review, Submissions, Re-registrations, market extensions, and responses.
Safety/Housekeeping: Keep work areas clean and free of hazards or dangerous conditions. Perform duties in accordance with Health, Safety, and Environmental standards. Participate in site safety programs , identify and report safety hazards or unsafe behavior.
Planning: Lead efforts to ensure that the group is audit ready, are meeting customer deadlines, and CAPAs/action items are tracked and completed in a timely manner.
Technical: To perform compliance activities that ensure required quality and safety standards are being met for our products. Perform compliance activities of complex nature as per schedule and per standards/SOPs. Develop your knowledge to become a SME to the compliance team on topics such as: GMPs, Risk Management, Change Control (PPC, ECN), Annual Product Review (APR), Audit, Gap Assessment, Regulatory documentation (Submissions, Re-registrations, market extensions, responses), validation (AS&T/MS&T), external standards and the Novartis Quality Manual. Develop a high level of integrity and have a desire to comply with regulations and standards. Approve, review, and provide meaningful actionable feedback on AS&T/MS&T projects and documentation. Knowledge of cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices. Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach. Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes. Possess understanding of the relationships between Manufacturing, Quality Control, Quality Assurance, Compliance, R & D and Regulatory Affairs. Write and take ownership for compliance SOPs. Review investigative testing to support laboratory investigations; participate in root cause analysis. Participate in self-inspection program as guest assessor or lead auditor (CQA). May serve as manufacturing site e-compliance officer (computer system validation experience required)
Team: Lead and support coworkers to enhance overall capability of the organization. Lead in problem solving and troubleshooting of compliance issues and methodology.
Interfaces: Effective communication skills both verbal and written concerning compliance actions with other departments which may include affiliates, R&D, Regulatory Affairs, Global, and other manufacturing sites. Participate in global compliance initiatives as required.
Compliance Specialist - QA
- Minimum: Bachelor's Degree or equivalent years of directly related experience
- Desired: Bachelor's Degree in Microbiology, Biology, Chemistry or a science-related discipline
- The ability to fluently read, write, understand and communicate in English
- 2 Years of Relevant Experience
Fort Worth, TX
QUALITY ASSURANCE AL
Alcon Research, Ltd.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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