303 Regulatory Guidelines Jobs - Page 9

The role of Formulation Regulatory Affairs Assistant Manager/Deputy Manager in the US Market requires a candidate with 7-10 years of experience and a qualification of M. Pharma / M.Sc. The responsibilities include hands-on experience in the preparation, review, and submission of ANDA/ANDS in the US Market, as well as expertise in life cycle management for products filed in the US market. The candidate should possess comprehensive knowledge of regulatory guidelines/requirements and provide necessary regulatory inputs to cross-functional teams during product development and manufacturing stages. Understanding US regulatory submission requirements, maintaining regulatory databases, and publishing regulatory dossiers in eCTD format are key responsibilities. Reviewing technical documentations for dossier submission is also part of the role. The ideal candidate should have hands-on expertise in ANDA/ANDS filing, a stable background in a Pharma company, experience with US submissions, and familiarity with regulatory guidelines. Interested candidates with relevant experience are requested to share their CVs by emailing rashmi.gupta@biocon.com. When applying, candidates are required to mention their total experience, current CTC, total number of ANDA/ANDS filings, involvement in pre-approval activities, notice period, and willingness to work onsite in Bangalore (5 days working).,

We are seeking a dedicated and innovative Product Development Executive with a minimum of 12 years of experience in the field of cosmetology. In this role, you will be responsible for the end-to-end process of creating skincare, haircare, and personal care products. The ideal candidate should possess practical expertise in cosmetic applications, along with a sharp understanding of beauty trends and consumer preferences. Your primary duties will include assisting in the design and assessment of new cosmetic items, offering technical insights on product characteristics based on your cosmetology knowledge, collaborating with the R&D team for formulation trials, and maintaining detailed records of samples and testing outcomes. It will also be crucial for you to conduct thorough market research to keep abreast of emerging trends, ingredients, and competitor products. Furthermore, your role will involve engaging in sensory testing, providing valuable feedback for enhancing formulations, working closely with marketing and packaging teams to ensure product functionality and aesthetics, contributing to the development of training materials for internal staff and end users, and ensuring strict compliance with safety and quality standards throughout the product development phase. The key qualifications for this position include a degree or diploma in Cosmetology, a profound understanding of cosmetic formulations, ingredients, and product categories, a keen awareness of beauty standards and consumer behavior, exceptional attention to detail, strong communication and coordination abilities, the capacity to evaluate product performance from a cosmetologist's viewpoint, and a basic knowledge of regulatory requirements within the cosmetics industry. If you meet the aforementioned criteria and are interested in joining our team, please be prepared to answer the following questions during the application process: - Are you based in Nagpur or willing to work at our Wadi Rd Nagpur location - Do you have prior experience in a Product Development Executive role - Please provide details on your current location, current salary, expected salary, and notice period. This is a full-time, permanent position, offering benefits such as Provident Fund. The work location is in person.,

As a Team Member, you will be reporting functionally to the Group Lead/Team Lead and administratively to the Department Head. Your educational background should include a B.E/B.Tech/M.Tech degree in Mechanical/Automobile/Electrical Engineering. Having 5 to 7 years of experience in the field is essential for this role. Your responsibilities will include having a basic understanding of the chassis system, design aspects, and functions. You should also be familiar with part selection and the issues encountered during vehicle assembly. Experience with simulation software such as ADAMS, CARSIM, and Matlab is required. Additionally, you should possess knowledge of K&C simulation, ride and handling simulation, and tire modeling. Understanding vehicle dynamic parameters and terminologies related to ride, handling, and braking will be crucial for this role. You will need to estimate the impact of vehicle parameters on RHB and collaborate with testing teams to analyze failures. Interpreting results, identifying failure modes, and suggesting improvements for meeting performance criteria will be part of your responsibilities. In terms of competencies, you should have a thorough understanding of automotive engineering and regulatory guidelines and standards (e.g., SAE, JATMA, ETRTO, and AIS). Hands-on experience with chassis parts, knowledge in vehicle dynamics, ride handling, tire, and control systems, as well as familiarity with CAD software like UG NX, are required. Experience in project management will be an added advantage, and a minimum of 2 years of on-road driving experience is a must. From a behavioral standpoint, you should possess excellent interpersonal skills, effective communication and presentation skills, achievement orientation, teamwork abilities, and networking skills. Specific skills that are essential for this role include proficiency in MS Office, driving skills, and expertise in UG-NX, ADAMS, CARSIM, and Matlab.,

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products cover various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, benefiting millions of patients worldwide. For more information about Azurity, please visit www.azurity.com. Azurity Pharmaceuticals is committed to fostering an inclusive workplace and is proud to be an Equal Opportunity Employer. The company attributes its success to its talented and dedicated team that prioritizes improving patients" lives by incorporating the best science and commitment to quality in all aspects of its work. Azurity seeks individuals who are highly motivated, possess integrity, dedication, and a creative spirit to excel within the organization. As a part of the Clinical Development team at Azurity, the Manager, Clinical Development plays a vital role in supporting early development activities across multiple therapeutic areas. Reporting to the Director, Clinical Development, the candidate will collaborate with stakeholders and team members to ensure scientific excellence, build effective relationships across Research & Development, and optimize the design and analysis of clinical investigations. **Principle Responsibilities:** - Design studies with a focus on technical, regulatory, and formulation aspects. - Collaborate with program managers and study teams to develop study plans aligned with the overall development plan and key milestones. - Ensure compliance with GCP, local and target regulatory guidelines, study protocols, and identify and address areas of concern. - Oversee study operations, including initiation, monitoring, and closeout, sample shipment, and communication with CROs, involving travel to CRO locations and study sites. - Independently perform non-compartmental PK analysis, PK modeling, and IVIVC communication of trial status and data to cross-functional teams. - Manage data repository, TMF, and critical study documents, proposing alternative strategies to optimize time, cost, and resources. - Contribute to the development, review, and approval of clinical study documents, such as ICF, IB, CRFs, study reports, and regulatory documents. **Qualifications And Education Requirements:** - Master's, Pharm.D, or PhD degree in clinical research, pharmacology, or equivalent field. - Minimum 6 years of pharmaceutical industry experience, with 4-5 years of experience in Phase 1 or 2 clinical development. - Sound understanding of US and ex-US regulatory clinical requirements, drug development continuum, and knowledge of regulatory approval processes. - Familiarity with ICH guidelines, GCP, biostatistics, and pharmacokinetics. - Strong organizational, interpersonal, and communication skills with the ability to work collaboratively in a cross-functional team. - Excellent analytical, problem-solving, and communication skills. By applying for this role, you confirm your ability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have concerns or disabilities that may affect your performance, please inform HR in advance.,

You will be responsible for assessing, analyzing, and appraising credit proposals ranging from 5 Crore to 25 Crore for commercial banking clients. Your primary goal will be to make sound credit decisions that strike a balance between fostering business growth and adhering to risk management principles. This role will require you to conduct thorough financial analysis, identify risks, and compile comprehensive credit notes that align with the bank's credit policy and regulatory guidelines. In addition to the credit assessment tasks, you will also be responsible for submitting control returns to ensure compliance with internal controls and regulatory requirements. Your attention to detail and ability to interpret complex financial data will be crucial in this aspect of the role.,

Credit Assessment, Risk Management, Loan Approval Process : Evaluate loan applications and creditworthiness of applicants based on financial data and other relevant factors. Perform detailed analysis of financial statements, bank statements, and credit reports. Assess repayment capacity and recommend appropriate loan structures. Identify, analyze, and mitigate potential credit risks. Ensure compliance with internal credit policies and regulatory guidelines. Conduct periodic portfolio reviews to identify early warning signals. Coordinate with sales and operations teams for smooth processing of loan applications. Approve or recommend loans within delegated authority limits. Liaise with legal and technical team for finalization.

Credit Assessment, Risk Management, Loan Approval Process : Evaluate loan applications and creditworthiness of applicants based on financial data and other relevant factors. Perform detailed analysis of financial statements, bank statements, and credit reports. Assess repayment capacity and recommend appropriate loan structures. Identify, analyze, and mitigate potential credit risks. Ensure compliance with internal credit policies and regulatory guidelines. Conduct periodic portfolio reviews to identify early warning signals. Coordinate with sales and operations teams for smooth processing of loan applications. Approve or recommend loans within delegated authority limits. Liaise with legal and technical team for finalization.

Credit Assessment, Risk Management, Loan Approval Process : Evaluate loan applications and creditworthiness of applicants based on financial data and other relevant factors. Perform detailed analysis of financial statements, bank statements, and credit reports. Assess repayment capacity and recommend appropriate loan structures. Identify, analyze, and mitigate potential credit risks. Ensure compliance with internal credit policies and regulatory guidelines. Conduct periodic portfolio reviews to identify early warning signals. Coordinate with sales and operations teams for smooth processing of loan applications. Approve or recommend loans within delegated authority limits. Liaise with legal and technical team for finalization.

You should have a minimum of 5-11 years of experience in authoring high-quality CMC documentation for US FDA submissions, including Original ANDA/Deficiency responses/Post approval supplements/Annual reports. Your responsibilities will include identifying required documentation for US regulatory submissions, ensuring technical congruency and regulatory compliance, reviewing and identifying content issues with source documents, and keeping knowledge up to date with regulatory guidelines. You must have a B. Pharm/M. Pharm qualification and possess hands-on experience with eCTD software, as well as a strong understanding of CTD/eCTD requirements for submission of dossiers. Additionally, you should be proactive in identifying authoring issues, coordinating with stakeholders for technical support, and contributing to regulatory strategy and critical issue identification. Desired skills for this role include good technical knowledge, review skills, ability to try new approaches when faced with challenges, and a positive analytical and learning attitude. You will also be responsible for attending to e-publishing requirements throughout the project lifecycle and ensuring timely delivery of approved technical source documents in accordance with project timelines.,

Responsibility for conducting Chemical/Instrumental testing of raw material samples to ensure quality standards are met for products manufactured at Sun Pharmaceutical Industries Ltd, both for the domestic market and export to emerging markets. This includes analyzing and reporting stability and finished goods samples, monitoring gowning and sanitation practices, and ensuring compliance with standard operating procedures for analytical instruments. Responsible for system upgrades in alignment with Corporate Quality (CQ) and regulatory guidelines, operating analytical equipment in quality control during assigned shifts, and maintaining accurate documentation and record-keeping practices following Good Documentation Practices (GDP) and laboratory protocols. Supporting internal audits, regulatory inspections, and FDA audits by adhering to best practices and following all cGMP regulations as per Schedule M. Ensuring safety procedures are followed when handling analytical equipment and hazardous materials, completing assigned trainings to address identified training needs, and calibrating analytical equipment as per calibration procedures. Maintaining analytical equipment and laboratories in optimal working condition, overseeing stock levels of working standards, columns, reagents, chemicals, and glassware, and following procedures for non-conforming results as outlined in Standard Operating Procedures (SOPs) related to Out-of-Trend (OOT), Laboratory Incidents, and Out-of-Specification (OOS) results. Adhering to administrative procedures regarding attendance, leave, and other benefits in compliance with company policies and regulations.,

The responsibilities of this role include performing analysis of raw materials, intermediates, and finished products of Active Pharmaceutical Ingredients (APIs) according to approved specifications and Standard Operating Procedures (SOPs). You will be responsible for operating and maintaining analytical instruments such as HPLC, GC, UV-Vis Spectrophotometer, FTIR, Karl Fischer, Melting Point Apparatus, etc. Additionally, you will review and verify analytical data, ensuring proper documentation in accordance with cGMP and GLP guidelines. Preparation and standardization of volumetric solutions and reagents, carrying out stability studies as per ICH guidelines, and ensuring timely calibration of laboratory instruments are also key responsibilities. Method validation/transfer activities as per regulatory and internal requirements, participation in investigations related to OOS/OOT/Deviations and CAPA implementation, and coordination with QA, Production, and R&D departments for smooth workflow are essential tasks. Compliance with safety protocols and maintaining a clean and organized lab environment are also part of the role. The ideal candidate should have hands-on experience in analytical techniques, especially HPLC/GC. A good understanding of regulatory guidelines such as ICH, WHO, USFDA, etc., is required. Strong documentation and communication skills are essential, and experience in a regulated API manufacturing unit is preferred. This position falls under the Pharmaceutical & Life Sciences industry, specifically in the Corporate Quality Control department. It is a Full Time, Permanent role.,

Responsibility for conducting Chemical and Instrumental testing on samples of raw materials. Ensuring the quality of products manufactured by Sun Pharmaceutical Industries Ltd for both domestic and emerging markets. Implementing system upgrades in alignment with CQ and regulatory guidelines. Analyzing and reporting stability and finished goods samples when necessary. Monitoring gowning and sanitation practices within the operational area. Ensuring compliance with standard operating procedures for analytical instrument operation. Operating analytical equipment in quality control as per assigned shifts. Adhering to good documentation procedures and recording results as per SOP on GDP and laboratory practices. Supporting internal audits, regulatory inspections, and FDA audits with best practices. Adhering to cGMP regulations as per schedule M. Maintaining safety protocols for handling analytical equipment and potential hazards. Completing assigned training as per identified training needs through organized sessions or self-study. Calibrating analytical equipment as per calibration procedures for assigned responsibilities. Keeping analytical equipment and laboratories in good operational condition. Managing stock levels of working standards, columns, reagents, chemicals, glassware, etc. Following procedures for non-conforming results as outlined in SOPs for OOT, Lab Incidents, and OOS. Complying with administrative procedures related to attendance, leave, and other benefits.,

The role we are offering is for a Block Head to lead a key production block within our injectable manufacturing facility. Your responsibilities will include overseeing end-to-end manufacturing operations, managing a team of production staff, driving process optimization, ensuring regulatory audit readiness, maintaining compliance with cGMP standards, implementing changes, overseeing equipment and maintenance, coordinating cross-functionally, and managing inventory and resources. You should have a degree in Pharmacy, Engineering, or a related field, along with proven experience in sterile/injectable manufacturing. Strong leadership and team management skills are required, as well as knowledge of regulatory guidelines such as USFDA and EU standards. Hands-on experience with production equipment, QMS systems, and shop floor excellence tools is also desired. If you are ready to take on the challenge of leading a production block in a fast-paced, quality-driven environment, we are excited to hear from you.,

You will be responsible for providing statistical input to the design, analysis, reporting, and interpretation of clinical studies, as well as contributing to publications. Utilize SAS or other software to develop custom programming code for generating tables, data listings, graphs, and derived datasets as specified in the protocol or statistical analysis plan. Ensure that all outputs meet quality standards and project requirements. Perform validation programming and collaborate with other Programmers, Biostatisticians, and project team members to resolve any discrepancies or findings. Keep the project team informed of programming progress and any issues requiring their attention. Adhere to applicable SOPs and relevant regulatory guidelines. Manage scheduling and time constraints across multiple projects simultaneously. Set goals based on management priorities and adapt to timeline or priority changes by reorganizing daily workload. Prepare in advance for internal meetings, contribute ideas, and show respect for the opinions of others. Demonstrate willingness to collaborate with team members, assist with projects, and support initiatives as necessary to meet business needs. Negotiate and establish accurate time estimates for completing study activities with internal team members and statistical management. Ensure completion of project activities within the allotted timeframe. Assist in drafting regulatory submissions and stay updated with current literature and research new methodologies. Identify, develop, and implement novel statistical methodologies to support medicine development. Uphold scientific integrity and animal welfare in all activities. Interact with global statisticians and implement their recommendations locally. Create and maintain standard macros and applications to enhance department efficiency. Actively participate in process/quality improvement initiatives, standardization efforts, and other non-clinical activities. Contribute to mentoring other team members, develop training courses, present training materials, provide feedback, and guide new associates in the process. Engage in knowledge-sharing activities to foster a collaborative work environment.,

About the role: The organization is looking for an experienced and detail-oriented professional to manage treasury operations within their NBFC business. The ideal candidate will have 5-7 years of experience in treasury operations, with a strong grasp of both front-end and back-office processes. This role is crucial in ensuring accuracy, compliance, and efficiency in all treasury-related activities. Key Responsibilities: - Oversee daily treasury operations including fund transfers, investment settlements, bank reconciliations, and cash flow monitoring. - Ensure timely and accurate execution of money market and capital market transactions. - Coordinate with front office teams on trade confirmations, settlements, and reconciliations. - Handle treasury back-office functions such as: a. Trade confirmation matching and discrepancies resolution b. Settlement instructions and coordination with custodians/banks c. Ensuring timely accounting entries and ledger postings d. Managing deal documentation, custody, and audit trail maintenance e. Reconciliation of nostro and general ledger accounts - Monitor liquidity positions and support short-term funding and investment activities. - Ensure compliance with internal controls, SOPs, and regulatory guidelines (RBI, SEBI, etc.). - Assist in preparing regulatory and internal MIS reports related to treasury. - Support automation of treasury workflows and contribute to process enhancements. - Coordinate with auditors and internal teams during treasury audits and reviews. Desired Profile: - 5-7 years of relevant experience in treasury operations, preferably within an NBFC or financial services institution. - Solid understanding of treasury instruments, settlement processes, and back-office functions. - Familiarity with banking platforms, treasury systems (TMS), and Excel-based reporting. - Knowledge of applicable RBI guidelines, investment compliance, and operational risk controls. - Strong communication, analytical, and organizational skills,

Role & responsibilities Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements. Prepare, execute, and review Cleaning Validation protocols and reports . Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines. Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting. Ensure that all validation activities are compliant with cGMP, regulatory guidelines , and internal SOPs. Perform gap assessments, risk assessments , and deviation handling related to validation. Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution. Assist in internal audits, regulatory inspections , and prepare responses to audit observations. Maintain and update validation master plans and SOPs regularly. Skills & Competencies B. Pharm / M. Pharm / M.Sc. in relevant field. Minimum 4 years of hands-on experience in QA validation functions in a regulated pharmaceutical manufacturing environment. Strong understanding of equipment and utility qualification, cleaning validation, CSV, and process validation . Familiar with guidelines such as GAMP 5, 21 CFR Part 11, ICH Q8-Q10 , and applicable regulatory standards. Good documentation and analytical skills. Proficient in MS Office , knowledge of QMS software is an advantage. Strong communication and coordination skills.

Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process Digital Journey"s new initiatives features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

As a Customer Service Representative, you will be responsible for analyzing and resolving customer queries through calls. You will also support the execution and implementation of process improvements within the CRM team under the guidance of the Team Lead. It will be your duty to enhance the overall Customer Experience by addressing customer issues promptly and ensuring timely resolution of all concerns. Your role will require strict adherence to all Company Policies, procedures, code of conduct, and regulatory guidelines while interacting with customers. Additionally, you will be expected to propose effective strategies for promoting the Client's products and services to enhance customer satisfaction. Delivering exceptional customer service in a friendly and courteous manner will be a key aspect of your responsibilities. You must possess a comprehensive understanding of the products and services offered by the Client to address inquiries effectively. Furthermore, your ability to think creatively and suggest innovative ideas that improve operational efficiency, internal controls, or customer service will be highly valued.,

As a Polymorph Screening Scientist at Morepen Proprietary Drug Research Pvt Ltd. (MPDRPL), your primary responsibility will be to lead the screening and selection of solid forms for drug candidates. You will play a crucial role in improving the physicochemical properties of active pharmaceutical ingredients (APIs) by overseeing polymorph screening activities. It is essential to identify the most stable and bioavailable forms of drug substances for regulatory submissions. Collaborating with cross-functional teams, you will mentor junior scientists and drive advancements in solid-state drug discovery. Your key responsibilities will include overseeing the screening of potential polymorphs, solvates, and hydrates for APIs, interpreting and analyzing solid-state data, scaling up identified novel polymorphs, collaborating with various teams to align polymorph selection with drug formulation strategies, preparing regulatory-compliant data for filings, troubleshooting any issues related to polymorph stability, and ensuring accurate documentation and reporting of experimental protocols and findings. The deliverables expected from you include the identification and characterization of stable polymorphs and crystal forms for drug candidates, detailed screening reports, regulatory-compliant data for solid-state forms, and methodologies for high-throughput screening, scaleup, and solid-state characterization. To qualify for this role, you should hold a Ph.D. in Pharmaceutical Sciences, Solid state Chemistry, Chemistry, or a related field, with a focus on solid-state chemistry or materials science. Alternatively, a Master's degree with equivalent experience will be considered. You should have a minimum of 6+ years of industry experience in solid-state chemistry, polymorph screening, or pharmaceutical development and proven expertise in solid-state characterization techniques and polymorph screening methods. Proficiency in solid-state characterization methods, high-throughput screening techniques, and knowledge of computational techniques for polymorph prediction are essential technical skills required for this role. In addition to technical skills, you should possess excellent problem-solving, troubleshooting, and decision-making skills. Effective communication skills, both written and verbal, are crucial for presenting complex data to diverse audiences. Being detail-oriented with strong organizational and documentation skills will contribute to your success in this role at MPDRPL.,

You will be responsible for supporting regulatory and safety assessment services as an Expert in PDE (Permitted Daily Exposure), OEL (Occupational Exposure Limit), and QSAR (Quantitative Structure-Activity Relationship) Assessment. Your strong background in Pharmacology or Toxicology will be essential for preparing PDE/OEL reports and conducting QSAR assessments. Your responsibilities will include preparing PDE/OEL reports in accordance with regulatory guidelines, conducting QSAR assessments to evaluate chemical risks, collaborating with cross-functional teams to ensure compliance, analyzing and interpreting toxicology and exposure data, and staying updated with industry best practices and regulatory guidelines. To qualify for this role, you should have an MSc/PhD in Pharmacology or Toxicology, 2-5 years of relevant experience in PDE/OEL and QSAR assessments, a strong knowledge of toxicological risk assessment methodologies, experience with regulatory requirements related to exposure limits, and excellent analytical and problem-solving skills.,

A leading NBFC company is keen to hire a SQ/Q - CA/CS for the Compliance Manager (Internal auditor) to lead and enhance the internal audit and compliance framework by conducting risk-based audit & identify gaps to ensure timely resolution. Required Candidate profile -3+yrs exp in banks/ NBFC Co. for process review, risk Assesment, Internal controls -Hands-on with compliance monitoring tool -RBI regulations for NBFC or banking Industry -good communication skills

The Quality Control (QC) Reviewer plays a crucial role in ensuring the accuracy, completeness, and compliance of laboratory and clinical data with regulatory guidelines, company policies, and industry standards. Your responsibilities include reviewing raw data, study documentation, and analytical reports to ensure adherence to protocols and regulatory requirements. By identifying discrepancies and errors, you will provide recommendations for corrective actions to maintain data integrity. Collaboration with laboratory analysts, study coordinators, and quality assurance teams is essential to resolve issues related to data accuracy and compliance. As a QC Reviewer, you will document your findings meticulously, preparing detailed reports for management and regulatory bodies. Additionally, you will participate in audits and inspections to uphold quality standards. To excel in this role, you should hold a Bachelors/Masters degree in Life Sciences, Pharmacy, Chemistry, or a related field. With 2-6 years of experience in Quality Control/Quality Assurance within the pharmaceutical or biotech industry, you are expected to have a strong understanding of GLP, GCP, FDA, EMA, and ICH guidelines. Proficiency in reviewing analytical data, clinical study reports, and laboratory documentation, along with excellent attention to detail and problem-solving skills, are essential. Effective communication and interpersonal skills are necessary to collaborate with cross-functional teams. Moreover, staying updated with regulatory changes and industry best practices will contribute to enhancing the organization's quality standards. Experience with bioanalytical, clinical, or preclinical study reviews, knowledge of electronic data capture (EDC), and the ability to handle multiple projects with tight deadlines are preferred skills for this role. Proficiency in Microsoft Office and Laboratory Information Management Systems (LIMS) would be advantageous.,

The Third Party Management Operations (TPM Ops) provides operational support, process guidance, and quality assurance and quality control oversight to businesses across Citi, leveraging a central utility infrastructure, standardized processes, and operating procedures to execute robust risk management activities throughout the third-party management life cycle. As the Program Manager, you will provide full leadership and supervisory responsibility. You will offer operational/service leadership and direction to team(s) and apply in-depth disciplinary knowledge through the provision of value-added perspectives or advisory services. Your role may contribute to the development of new techniques, models, and plans within your area of expertise. Strong communication and diplomacy skills are required, along with responsibility for volume, quality, timeliness of end results, and shared responsibility for planning and budgets. You will provide guidance to internal stakeholders, monitor the timely and effective completion of activities related to the Third Party lifecycle, and ensure data accuracy for reporting third-party related metrics. Additionally, you will focus on keeping the motivation and development of the team through professional leadership, including duties such as performance evaluation, compensation, hiring, disciplinary actions, and terminations, as well as directing daily tasks and responsibilities. Your responsibilities will include establishing and overseeing the application of operational risk policies, technology, and tools, and governance processes to create lasting solutions for minimizing losses from failed internal processes, inadequate controls, and emerging risks. You will independently assess risks and drive actions to address root causes leading to operational risk losses, challenge historical and proposed practices, and look for ways to improve the current process by sharing best practices with senior leadership. You will participate in senior leadership meetings to analyze documentation and processes, assist senior management in gathering data for executive level reporting, and take ownership of specified projects and tasks. As an SME to senior stakeholders and/or other team members, you will manage larger teams and drive them to deliver the highest quality work on Third Party Management. It is essential for you to demonstrate strong knowledge about Third Party Lifecycle Management, Regulatory guidelines, Contract Terms & conditions, Information Security, Regulations (OCC, GDPR, Data Privacy Laws, and Country-specific Local Laws, etc.). You will provide process guidance and support to Third Party Officers (TPOs), Business Activity Owners (BAOs), and other business stakeholders on end-to-end Third-Party Management requirements, set up periodical review meetings with all stakeholders, facilitate and coordinate with various Policy Owners, and execute various third-party risk assessment controls. Additionally, you will verify third parties" policies and procedures for compliance with Citi's policies and procedures, identify and report gaps to senior management, drive your team to identify opportunities for better control and productivity enhancement, analyze data and forecast trends regarding inherent risks associated with third parties, and work with the Operations standards team to lay out the framework of new processes. You will be responsible for coordinating with internal and external auditors, ensuring timely and accurate submission of all deliverables, addressing observations and taking corrective action accordingly, driving and implementing process changes in line with new emerging risks and regulatory requirements, and appropriately assessing risks when making business decisions. Your role will involve supervising the activity of others and creating accountability for maintaining standards. Qualifications: - Minimum 12+ years of working experience in the financial services/Banking industry - Preferred 6+ years of direct, relevant experience in third-party risk management, operational risk management, or Audit related work - Minimum 3 years of Operational Leadership Experience including delivering in a high-volume, goal-based production/operations-based environment - Knowledge of third-party management risk and control methodologies and best practices - Team management skills preferred - Supply chain management experience preferred Education: - Bachelor's degree required - Master's Degree preferred - Professional Qualifications including CA/ICWA/ACS etc. - Project Management experience in process standardization & Automation - Preferred external certification CISA/CIA/CSCP/CPSM Citi is an equal opportunity and affirmative action employer.,

Roles and Responsibilities Conduct audits of bank branches, identifying areas for improvement and providing recommendations for enhancement. Ensure compliance with regulatory guidelines, internal policies, and procedures. Prepare detailed audit reports highlighting key findings, risks, and control gaps. Collaborate with branch management teams to implement corrective actions and monitor progress. Maintain accurate records of all audit activities, including documentation of audit plans, findings, and follow-up actions. Desired Candidate Profile 2-5 years of experience in auditing or related field (banking and financial industry preferred). Strong understanding of audit documentation, audit compliance, audit report preparation, auditing principles, and regulatory guidelines. Excellent analytical skills with ability to identify trends and patterns in data analysis. Strong in communication skills with ability to present complex information clearly both verbally and written. What We Offer: Opportunity for career growth and professional development. Dynamic and collaborative work environment.

Job Summary We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards. Roles & Responsibilities You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods. You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples. You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities. You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development. You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department. You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed. You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour. You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency. You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions. You will be responsible to evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process. You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements. You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment. You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results. You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy. You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions. You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. Qualification Educational qualification: Masters in Science/ Organic chemistry Minimum work experience: 5 years of experience in analytical method development Skills & attributes: Technical Skills Have work experience on Process scale up of Active Pharmaceutical Ingredients. Experience in Process Optimization (Manufacturing) Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis. Proven experience in method validation and documentation in compliance with regulatory requirements. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/