Senior Associate, Quality Compliance

Sun Pharmaceutical Industries • Princeton, NJ

66d • $90,000 - $112,500

About The Position

The Quality Assurance Specialist is responsible for the batch certification review of site QA activities related to manufacturing and packaging records, as well as all supporting documentation. This includes ensuring compliance with Standard Operating Procedures (SOPs), equipment and instrument maintenance, calibration, qualification, and validation in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA++ principles. The role also provides support during regulatory, corporate, and internal audits.

Requirements

• Minimum of a Bachelor's degree required.
• Strong understanding of cGMPs, particularly those related to documentation practices.
• Ability to work effectively within an international, multicultural matrix organization.
• Proficiency in software applications including MS Word, Excel, PowerPoint, Outlook, Acrobat Reader, TrackWise, LMS, and other relevant systems.
• Knowledge of project management principles and tools.
• Excellent communication, interpersonal, and organizational skills.
• Minimum of 7 years of experience in the pharmaceutical industry.
• Experience working in a global, multicultural matrix organization.

Nice To Haves

• Participation in seminars and training courses is considered an asset.

Responsibilities

• Support batch certification activities for commercial distribution in the USA and Canada, ensuring timely execution aligned with production schedules and deliverables.
• Serve as a subject matter expert in sterile manufacturing and packaging processes.
• Review investigations related to site incidents and deviations (planned/unplanned, FARs), ensuring corrective and preventive actions are appropriate and effective.
• Ensure compliance with regulatory requirements for product, process, equipment, and release procedures.
• Provide support during regulatory audits, internal and external inspections, and corporate audits. Responsible for follow-up on operational findings from FDA and other regulatory bodies.
• Participate in and conduct mock inspections to prepare the facility for audits; assess system gaps and review documentation for compliance with current regulations and cGMP standards.
• Identify compliance issues and support implementation of continuous improvement initiatives.
• Promote adherence to SOPs and policies, ensuring procedures reflect current practices.
• Perform additional assignments as required.

Benefits

• Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program.
• Employees also receive various paid time off benefits, including vacation time and sick time.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees