QC, Compliance Specialist

Sun Pharmaceutical Industries Limited; New Brunswick (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player in the pharmaceutical sector is looking for a dedicated professional to manage laboratory compliance activities. This role involves preparing and reviewing essential technical documents, ensuring adherence to regulatory guidelines, and collaborating with various stakeholders to achieve departmental goals. The company emphasizes integrity, innovation, and a commitment to making health accessible. If you have a strong background in compliance and a passion for improving lives through quality medicines, this opportunity is perfect for you.

Benefits

Medical, Dental, Vision Benefits

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Prescription Drug Coverage

Income Protection – Short Term and Long Term Disability Benefits

Retirement Benefits - 401k Company Match

Group Life Insurance

Wellness Programs

Corporate Discounts on personal services

Qualifications

• Minimum of four years of experience in the pharmaceutical industry.
• Strong understanding of FDA guidelines and cGMP practices.

Responsibilities

• Manages laboratory compliance activities for assigned functions and projects.
• Prepares and reviews technical documents according to company standards.
• Ensures compliance with cGMPs, DEA regulations, and site operating procedures.

Skills

Analytical Skills

Communication Skills

Project Management

Problem-Solving

cGMP Compliance Knowledge

Laboratory Instrumental Analysis

Education

BS in Chemistry or related discipline

Tools

Microsoft Office (Word, Excel, PowerPoint, Access)

Job description

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!

• Medical, Dental, Vision Benefits
• Health Savings Account (HSA), Flexible Spending Account (FSA)
• Prescription Drug Coverage
• Telehealth and Behavior Health Services
• Income Protection – Short Term and Long Term Disability Benefits
• Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

Sun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Our Code of Conduct

Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts of those who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.

DOWNLOAD OUR CODE OF CONDUCT

Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepares and reviews the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOPs according to company standards and FDA/ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. Reviews the USP and other compendia changes on a timely basis and updates the related documents to implement the changes and ensure compliance.

• Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOPs, compendial, ICH and FDA regulatory guidance.
• Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
• Evaluates compendial documents and reviews procedures for laboratory compliance.
• Evaluates Sun global documents (GQS and GSOP) against site-specific procedures and updates the site procedure accordingly.
• Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
• Generates change requests required for analytical documents and routes documents for review and approval. Maintains hard copies and electronic files of technical documents.
• Timely provides the QC documents required for CBE, PAS and ANDA submission to RA.
• Collaborates with colleagues and external partners to achieve individual and department goals.
• Ensures compliance with cGMPs, DEA regulations and site operating procedures under the direction of QC Management.
• Ensures Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed in a timely fashion.
• Ensures continuous laboratory compliance by adopting best industry practices and complying with procedure requirements.

Qualifications

• Minimum BS or equivalent degree in Chemistry or related discipline.
• Minimum of four (4) years of experience in the pharmaceutical industry.
• Good computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
• Must have an understanding of FDA guidelines, ICH guidance and DEA regulations. Ensures compliance with cGMPs, DEA regulations, safety and site operating procedures under the direction of Management.
• Must be familiar with proper cGMP practices for analytical laboratories and have working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
• Must have cGMP compliance knowledge and experience.
• Collaborates with colleagues and external partners to achieve primary department goals.
• Works in coordination with project plans and goals as assigned by Management.
• Demonstrated strong communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• Excellent project management and problem-solving skills.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).