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QC Compliance Specialist
4 weeks ago
OverviewSun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.Job SummaryUnder 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, SOPs accordingly to company’s standards and FDA/ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. Review USP and other compendia changes on a timely basis and update related documents to implement the changes and ensure compliance.ResponsibilitiesWrites technical documents such as methods, specifications, method validation protocols and reports, and method transfer protocols and reports based on corporate policies and SOPs, compendial, ICH and FDA regulatory guidance.Ensures the integrity and accuracy of all laboratory documents; assess overall document compliance with protocols, SOPs, policies, and regulations.Evaluates compendial documents and reviews procedures for laboratory compliance.Evaluates Sun global documents (GQS and GSOP) against site procedures and updates the site procedures accordingly.Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.Generates change requests for analytical documents and routes documents for review and approval. Maintains hard copies and electronic files of technical documents.Provides QC documents timely for CBE, PAS and ANDA submissions to Regulatory Affairs.Collaborates with colleagues and external partners to achieve 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.Promotes continuous laboratory compliance by adopting best industry practices and complying with procedure requirements.Work EnvironmentManufacturing/Production environment.Environmental & Physical RequirementsEnvironmental factors: noise, fumes, odors, gases, dust; exposure to various manufacturing environments.Hazards: operating near moving parts, working at height, exposure to burns, radiant energy, toxic chemicals, electric shock.Physical requirements: stand, sit, walk, use hands, reach, speak, hear; close vision and depth perception; ability to lift up to 50 lbs.TravelTravel estimate: Up to 5%.Education & QualificationsMinimum BS or equivalent in Chemistry or related discipline.Good computer skills and competence with Microsoft Office; knowledge of LIMS and SAP.Understanding of FDA guidelines, ICH guidance and DEA regulations; familiarity with cGMPs and laboratory practices.Working knowledge of analytical instrumentation and wet chemistry; strong communication and project management skills.English language proficiency: Intermediate-B1+ (CEFR).ExperienceMinimum of four (3) years of experience in the pharmaceutical industry preferred.EEO & NoticeWe provide equal employment opportunities for all current employees and applicants. Sun Pharmaceuticals is not accepting unsolicited resumes from agencies unless a valid written agreement exists.Disclaimer: The preceding job description outlines the general nature and level of work performed. It is not a comprehensive inventory of duties or qualifications and may be updated as needed. #J-18808-Ljbffr
