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SUN PHARMA · 21 hours ago

Senior Associate, Quality Compliance

Princeton, NJ

Full-time

Onsite

Mid, Senior Level

$90K/yr - $112K/yr

7+ years exp

Sun Pharma is the world’s fourth largest generics company with a strong presence in the U.S. The Quality Assurance Specialist is responsible for batch certification review and ensuring compliance with manufacturing and packaging records, while also supporting regulatory audits and continuous improvement initiatives.

Biotechnology

H1B Sponsor Likely

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

Qualification

CGMP knowledgeQuality AssuranceRegulatory complianceSoftware proficiencyProject managementInterpersonal skillsOrganizational skillsCommunication skills

Required

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

Preferred

Participation in seminars and training courses is considered an asset

Benefits

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) savings plan

Flexible spending accounts

Employee assistance program

Various paid time off benefits, including vacation time and sick time

Company

SUN PHARMA

Glassdoor3.8

Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India.

Founded in 1983

Mumbai, Maharashtra, IND

10001+ employees

http://www.sunpharma.com

H1B Sponsorship

SUN PHARMA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (15)

2024 (10)

2023 (6)

2022 (12)

2021 (9)

2020 (11)