QC, Compliance Specialist

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 - k Company Match on Day One (% 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 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. 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. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOP’s accordingly to company’s standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance. Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOP's, 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.  Evaluate Sun global documents (GQS and GSOP) against site specific procedures and update 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 file of technical documents. Timely provide the QC documents required for CBE, PAS and ANDA submission to RA. Collaborates with colleagues and external partners to achieve individual and department goals. Ensure compliance with cGMP’s, DEA regulations and site operating procedures under the direction of QC Management. Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion. Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements. Qualifications Minimum BS or equivalent degree in Chemistry or related discipline. Minimum of four 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 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).