ResponsibilitiesTo review the Raw material, packing material and finished product specification and to update department Head whenever required.  To carryout investigation in case of out of specification (OOS) and deviation and take the corrective and preventive action (CAPA). To ensure the calibration of all the analysis instruments is accurate. To sign off electronically the final document of sample set generated through Empower and all other softwares where (E-signature is applicable) for all the analysis in QC, stability & microbiology. To ensure the preparation of working standards as per the guidelines and pharmacopoeias. To ensure the review of calculation of the respective test protocol and daily release status. To ensure the testing of Raw material and packing material and analysis of in-process and finished product sample and it’s release according to standard operating procedure and specification. To ensure recording and documentation of all the data related to the testing on-line on daily basis and ensure the tractability of the same. To ensure preparation of the reagent and volumetric solutions. To support team members in preparation of SOPs. To review calibration reports. To escalate any abnormal results to department Head. To sign all the necessary test records and review the results of all the testing. To review real time analysis data as and when required. To review audit trails of analytical instruments as per defined procedure.

ResponsibilitiesThe Research Associate III is responsible for contributing to all phases of Extractable & Leachable studies carried out IH and at CROs. This would include study design as sample preparation, analysis, and data interpretation. Independently or with support of sub department manager, author and contribute to the experimental protocols, process and interpret data, author and review technical reports in English. Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need. Ensure compliance in all research, data collection and reporting activities. Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. Support the build out of the R&D- E&L laboratory. Develop and enhance technical capability through training and on job experience. Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs. Key contributor during experimental study designs, execution and review/approval at IH & CROs study.Qualification & ExperienceEducational Qualification: Master’s in pharmacy / Chemistry or Ph.D. in chemistry related field Experience range (desirable): Between 10-15 years.Must be well-versed in analytical chemistry, spectroscopy, and impurity quantitation and characterization, structure elucidation and possess knowledge in related disciplines. Must be able to critically analyze complex data. Experience in at least one of either LC-MS, HRMS, GC-MS or ICP-MS. Experienced in Analytical development and validation. Demonstrates ability to critically interpret chromatographic and complex spectroscopic data.

Responsibilities Drives adherence to SFE processes :, Call average, customer coverage, working days, SME trackers, prescription tracker, secondary sales and product sampling/demonstrations  To track all product and service quality related complaints and coordinate with National/Sales Manager/quality to ensure formal response and closure to complaints report it to PV & Quality  Competition & Market Mapping -- Track and gather market data, no. of indicated surgeries, gather and analyze competitor activities  P5 Implementation – Implementation of Marketing strategy and activations as per defined GTM  Identify and drive business development initiatives in his/her current /new accounts including training and education of paramedical staff  Ensure speedy and adequate availability of products in his/her accountsQualification & Experience B Pharma / B.Sc. / B.Tech with Masters in Management would be add on. Experience : 5 Years +

ResponsibilitiesDefine and lead the global regulatory strategy for post-approval lifecycle management of U.S. FDA-approved ANDAs/NDAs, ensuring alignment with business goals and regulatory expectations. Oversee the preparation, review, and submission of all CMC post-approval regulatory filings, including CMC Supplements (CBE-0, CBE-30, and PAS), Annual Reports (both active and inactive), REMS updates, general correspondences and controlled correspondences Serve as the primary regulatory authority on post-approval matters, providing expert guidance to executive leadership and cross-functional teams. Lead regulatory assessments and decision-making for complex changes, including site transfers, formulation changes, alternate APIs, etc.Qualification & ExpeirencePharm D or M. Pharma in a scientific discipline. Minimum 15+ years of pharmaceutical industry experience, with at least 10+ years in U.S. Regulatory Affairs focused on managing the lifecycle of generic drug products. Proven leadership (8+ years in a supervisory role) in independently managing a large regulatory team, as well as a large and diverse post-approval portfolio consisting of various, globally manufactured dosage forms and complex supply chains.

ResponsibilitiesComplaint Processing: Performs the functions associated with receiving, trending, logging and coordinating the return of the Samples for product quality related Complaints. This includes complaints received via phone, email, and internet. Utilize knowledge and experience from processing of live complaint calls to lead by example. Assists QAS Intake team management in handling of QAS Intake team activities : Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions. Collaborate with QAS Daily review team and/or closing team to discuss and calibrate on varying views on how records should be handled. Responsible for handling High Profile complaints. Conduct a day end review to ensure that proper justification is provided for and documented in all High Profile complaints.Qualification & ExpeirenceMinimum 1-4years of overall experience in Complaints handling, Bachelor’s degree of Pharmacy (B. Pharm) or Master’s Degree in Pharmacy (M. Pharm) and also MSC if candidate is fitting in criteria required Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate

ResponsibilitiesLeads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations. Ensure a current Quality Management System is in place and continuously improved Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications. Most senior professional and independent decision maker authority on product quality and potential market actions Assess and Mitigate Risks-- Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market. Work with the business to assure compliant and reliable supply Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.Qualification & ExpeirenceMinimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including: Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process, High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, 

ResponsibilitiesCandidate must be working independently alongside monitoring team of Quality Executives. Daily work involves Handling of Change Request Forms through Computerized software Handling of Computerized Training Management system related activities Preparation and Review of Certificate of Analysis (CoA) Analytical Result entries to SAP batch data Maintenance of SOPs and Internal guidelines in SAP Handling of GMP/ MIA certificate availability activity Managing various Quality Assurance documents and notificationsQualification & Experience4 - 7 years’ experience in Quality Assurance with 1-2 years team lead experience (preferably Pharmaceuticals) Experience in managing various Quality Assurance documents and notifications Proficient in MS Office

Qualification & Experience  EXPERIENCE (in Years) : 1–2 years      ELIGIBILITY : MBBS + Hospital Administration | Experience: 1–2 years with knowledge of NABH         

Qualification & Experience    EXPERIENCE (in Years) : 1–2 years        ELIGIBILITY : M.Sc. Nursing or B.Sc. Nursing | Experience: 1–2 years                       

Qualification & Experience  EXPERIENCE (in Years) : 2–4 yearsELIGIBILITY : Degree/Diploma in CSSD Technology | Experience: 2–4 years | Requirement: Para Medical Council Registration