Sr. Associate, Compliance

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 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.

Responsible for providing Quality Assurance support to Manufacturing Operations relative to the production of commercial and / or clinical products. Responsible for a diverse and challenging set of activities, all of which are related to maintaining quality standards aligned with US FDA cGMP, QSR, ISO and other applicable international regulations and guidance documents.

Risk Management aspects including Quality Alerts, Field Alert Reporting, Product Complaints, Recall, and Site Quality Management Review content. In addition, development of Quality Standards for functions managed within Quality Compliance, and driving overall GxP strategic direction for these quality activities, programs and objectives.

Perform in-process checks and inspections; review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released through incoming and in-process inspection process

Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal / customer audits. Facilitate review and support regulatory inspection management.

Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.

Collaborate with Corporate compliance group and implement global CAPA.

Support for major health authority inspections at site and provide input and support to inspection readiness / responses to drive consistency and clarity at the site. Provide oversight of quality activity outcomes resulting from regulatory inspections, commitments and filings.

Support compliance investigations as needed, in collaboration with others at the site.

Perform complaint investigations through analyzing returns and reviewing batch records, and provide written reports of findings.

Participate in compliance audits (internal and external) and correct deficiencies as required through the appropriate system.

Interface extensively on a daily basis with all departments.

Perform all principle duties that affect the quality of products and services within the guidelines of 21 CFR 210 / 211, 21 CFR 820, ISO 13485, the Canadian Medical Devices Regulation (CMDR), Medical Device Directive (MDD) and other applicable standards, laws and regulations wherever we do business.

Qualifications

High School Diploma required, Bachelor's degree in life sciences preferred.

Minimum of eight (8) years of experience in the FDA regulated medical device or pharmaceutical industry.

Experience with Trackwise, EDMS, and Mastercontrol preferred.

Must have experience with cGMP, QSR and ISO regulations.

Must have experience performing inspections and investigations.

Must have a thorough knowledge of quality system requirements.

Demonstrated excellent communication : verbal, written and presentation skills.

A self-starter with a hands-on approach and a can-do attitude.

A team building champion driving innovative cross functional synergies.

Excellent project management and problem solving skills.

Strong mathematical skills.

Demonstrated proficiency with Microsoft Word, Microsoft Excel, and Microsoft Outlook programs.