104 Mhra Jobs - Page 3

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

The Senior Executive - QA (Engineering Assurance) will be responsible for executing and reviewing qualification lifecycle documents for GMP equipment, utilities, and facilities. The role includes oversight of URS, DQ, IQ, OQ, and PQ protocols, engineering change controls, risk assessments (FMEA), and periodic requalification activities. This position works closely with Engineering, Validation, Projects, and cross-functional QA teams to ensure timely qualification and regulatory readiness. Key Responsibilities: QA review and approval of qualification protocols and reports (URS, DQ, IQ, OQ, PQ) Oversight on facility, utility, and equipment qualification activities QA support for engineering change controls and deviation handling Risk assessment and mitigation using tools like FMEA and HAZOP Periodic review and requalification planning Participation in internal/external audits and regulatory inspections Ensuring data integrity and documentation compliance across qualification records B. Tech / M. Tech / B. Pharm / M. Pharm / M. Sc. with specialization in Engineering, Life Sciences, or related field 5-8 years of relevant experience in QA Engineering or Qualification/Validation domain Strong knowledge of GMP regulations (USFDA, MHRA, EU) and qualification standards (ISPE, WHO, ICH Q9, Q10) Hands-on experience in equipment/facility qualification, HVAC, water systems, and cleanroom validations Excellent documentation review, risk assessment, and communication skills

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Job Overview Responsible for managing and maintaining Quality Management System (QMS) activities within the Supply Chain Management (SCM) department, including Change Control, Deviation, and CAPA management. Ensures daily operations and documentation are in compliance with cGMP and regulatory standards. Supports audit readiness and continuous improvement initiatives within SCM. Key Stakeholders: Internal QA/QC/Production Key Stakeholders: External Vendor and Auditors Reporting Structure SCM Head Experience Minimum 2 -4 years of relevant experience in the Pharmaceutical Industry , with hands-on exposure to SCM and QMS functions. Competencies Analytical thinking and problem-solving ability Strong communication and interpersonal skills Ability to collaborate cross-functionally Proactive and self-motivated approach to compliance and improvement initiatives Roles and Responsibilities: Manage and maintain Quality Management System (QMS) activities within the SCM department, including Change Control, Deviation, and CAPA. Ensure all SCM operations and documentation comply with cGMP, GDP, and relevant regulatory guidelines (USFDA, WHO, MHRA, etc. ). Act as a key interface between SCM and QA/QC/Production teams to ensure seamless quality compliance. Support audit readiness and manage audit-related documentation and follow-ups. Drive continuous improvement initiatives within SCM through effective implementation of QMS tools and RCA methods (Why-Why, FMEA, 6M, etc. ). Coordinate with vendors and external auditors to ensure compliance with quality and supply chain standards. Utilize ERP systems (SAP/Oracle/other SCM tools) to manage supply chain and QMS documentation. Contribute to vendor qualification processes and material management from a quality perspective. Foster cross-functional collaboration to resolve quality issues and enhance SCM performance. Report to the SCM Head, providing regular updates on QMS activities, audit outcomes, and improvement actions. MSc/BSc or MTech/BTech

About Apotex Inc. Job Summary Responsible for Calibration, Thermal Mapping, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Deputy Manager - Engineering and Maintenance at ARPL for day to day engineering activities of allotted Job responsibilities. Execute in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance work orders wrt instruments. Co-ordinate for all engineering department trainings as per established procedures. Execute / supervise with the help of contractor s on daily basis or as and when required for follow up and completion of calibration, thermal mapping, Qualification and other engineering cGMP documentation activities and projects. Execute / supervise the engineering department online documentation all time with respect to Risk Assessment / Calibration / Thermal Mapping / Planner / Logbooks. Update master calibration schedules, Thermal mapping schedules in SAP, update calibration records, calibration reports review and archival. Prepare Performance Qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe work place at ARPL all time in coordination to EHS department personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Works as a member of a team to achieve all outcomes. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, Passion; Demonstrates strong and visible support of our values. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory and compliance and safety requirements. Follow up with cross functional team for on time closure of CAPA, CCR, Deviations / investigations with respect to calibration and Thermal mapping. Notification creation, Confirmation, and TECO updation for PM & CM work orders in SAP PM module Execute Master data related activities in SAP. Preparation and review of Risk assesments. All other duties as assigned. Job Requirements Education Bachelors degree in Engineering. Knowledge, Skills and Abilities Should have knowledge in Calibration and Thermal Mappping and its related Documentation. Should have knowledge in QMS documentation. Should have knowledge in utilities systems and equipment s. Should have knowledge in Preventive maintenance process. Works effectively towards achieving the engineering compliance. Should have good interpersonal and communicational skills. Hands on experience in Track wise application, SAP and MS Office etc. Should have knowledge in ISPE, ISO and WHO Guidelines with respect to Calibration and Thermal Mapping process. Should have audit exposure to any of the regulatory audits like USFDA, MHRA, HC and TGA. Strives to drive projects related to engineering. Experience Minimum 8 years experience in Pharmaceutical Industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary Responsible for Qualification and validation, SOPs and Formats preparation, Training co-ordination and other Engineering GMP activities. Responsible for projects and other activities as assigned. Job Responsibilities Execute all engineering operation as per established ARPL standards and procedures. Reports to Assistant Manager - Engineering and Maintenance at ARPL for day-to-day engineering activities of allotted Job responsibilities. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Ensure preparation of protocols and completion of Facility Qualification, IOQ, PQ for modified and newly created area as per the organization requirements. Ensure completion of test like Air velocity and Number of air changes, Class of Air- Non-viable Particle count, Airflow Direction/Pattern & HEPA Filter integrity for Air handling unit qualification. Receipt and review of Qualification Reports and Certificates from qualification service provider. Ensure completion of Scheduled Qualification for the Equipment like Air Handling Units, LAF (Clean air stations), Pass box system, Dust Collectors, De-Dusting booth, Compressed Air System, Nitrogen plant, Water System, Access Control system, Etc., Execute / supervise the engineering department online documentation all time with respect to Equipment Qualification / Re-Qualification / Risk Assessment / Training / Re-Evaluation / Planner / Logbooks. Preparation, updating, Review and archival of Qualification protocols, filter replacement schedules, QSR documents. Prepare Performance Re-qualification protocols and reports in line with the cGMP requirements. Ensuring and maintaining safe workplace at ARPL all time in coordination to EHS personnel. Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements. Execute with quality assurance department for preparation and implementation of engineering department SOPs / Formats / System manual and other engineering documents. Ensuring and maintaining engineering inventory management /upkeep of minimum stock availability for engineering spares. Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification and other engineering cGMP documentation activities and projects. Coordinating and Attending training sessions on cGMP, Regulatory, SOP trainings, SAP trainings, latest technical & industrial developments related to Engineering. Address and resolve escalated complaints & grievances from user department. Performs all work in accordance with all established regulatory compliance and safety requirements. Notification creation, confirmation and TECO of Preventive Maintenance & Corrective Maintenance work orders in SAP Module. Demonstrate Behaviours that exhibit our organizational values values: Collaboration, Courage, Perseverance and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance program, Global Quality policies and procedures, Safety and Environment policies and HR policies. All other duties as assigned. Job Requirements Education Minimum Diploma Engineering/Bachelors degree in Engineering Knowledge, Skills and Abilities Having Knowledge in Calibration, Thermal Mapping, Qualification and its related Documentation. Having knowledge in QMS documentation. Having knowledge in utilities systems and equipment s. Having knowledge in Preventive maintenance process. Having good interpersonal and communicational skills. Having knowledge of ISPE, ISO and WHO Guidelines for pharmaceutical equipment and area Qualification. Shall have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA. Etc., Experience Minimum 3 years of experience for bachelor s degree or 5 years of experience for diploma in engineering in pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Accountabilities Scope of work: Principle accountabilities Collaborating with senior executives to establish and execute a sales goal for the region. Managing a sales team in order to maximize sales revenue and meet or exceed corporate set goals. Regional strategy and budget exercise Business development for growth of region. Achievement of Annual Budget Adopting the correct market entry strategies and aligning Organizational resources accordingly Effective Execution of assigned region. Implement pricing and market strategy Preferably direct contact with decision makes of major regional Generic companies. Identification of new molecules for launch in the US Market Increase market share of existing products and qualify as source with potential customers for existing and new products. Development Forecasting annual, quarterly and monthly sales goals. Review and do analysis of regional business to identify growth opportunities. Developing specific plans to ensure growth both long term and short term. Receivables management Coordinating with SCM team for effective distribution management ",

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. ",

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Assistant Manager QA Job Requisitions No : 13774 Job Description Purpose of Job Responsible for overall Monitoring and Compliance of documentation and IPQA activities of DS Manufacturing related to Manufacturing facility Responsible for APQR preparation related to CI & DS, Skill Required Good Review skills with exposure of Biopharma QA Roles and Responsibilites Review of new & revised documents i-e SOP, BPCR, MPCR, PTD, TTD, Validation Protocol, Report and QRM related to BBM facility, Review and to ensure timely completion of BPCR of products (CI and DS) manufacturing in BBM for release Authorized for batch release of Critical Intermediates, Drug substance and associated in-house media, buffer and column BPCRs, Review, monitoring and follow up for timely completion of CAPA, Deviations, Change Controls, OOT, OOS, IQA/external audit observations/, etc Handling and Assessment of Breakdowns, Alarms, SAP Incidents, ERN related to BBM facility Review of electronic data/audit trail data related to BBM facility, Monitoring and participation in process validation activities of BBM Review/Approval and compilation of Process validation documentation, Monitoring and participation in cleaning validation activities of BBM Review/Approval and compilation of cleaning validation documentation, Issuance of Working Cell Bank & Master Cell Bank, EPCBs and related documentation Ensuring physical reconciliation of cell banks, Qualification Required Sc Relevant Skills / Industry Experience Good Review skills QA Biopharma experience of more than 7-8 years, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Biotech, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment If someone asks for payment on our behalf, it is a scam Please report the incident to the local police or cybercrime unit Your trust and safety are important to us, Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Sr Executive Quality Assurance Job Requisitions No : 13749 Job Description Purpose of Job Preparation and Review of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Skill Required Having basic knowledge on Microsoft Word and Microsoft Excell Have knowledge of Minitab software for statstical evaluation of data, Roles and Responsibilites Preparation and review of PQR schedule, Planining of PQR compilation as per PQR schedule, Collection of data from all the CFT teams for compilation of PQR, Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software, Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same, Qualification Required Pharm or M Relevant Skills / Industry Experience Should have relevant experience in Regulatory approved plant, Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: SEZ, Ahmedabad, GJ, IN, 382213 Travel: 0% 25% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 26 May 2025

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies. 100% adherence to provided timelines for review of documents timely. Track and support in Top 07 projects. Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule. Ensure quality score minimum of 90% for each month. Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits. No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products. Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

About the Role: Grade Level (for internal use): 09 The Role This position is an individual contributor within the Internal Audit team responsible for performing audit engagements including U.S. Sarbanes-Oxley (SOX) Compliance testing. This position will contribute significantly to SOX testing efforts and evaluating compliance with corporate policies, assessing risks over the IT operating environment and identifying operational efficiencies. The Impact The IT SOX Specialist will work closely with your direct manager and the process owners to gain an understanding of key processes, key controls, identify control gaps by strengthening and monitoring the internal control environment to provide assurance in the accuracy of reported financial information for a leading data provider worldwide. Whats in it for you You will interact with key process owners and colleagues across the Company. You will also be responsible for completing the audits and projects as outlined in the Internal Audit Plan and play a critical role in assessing the effectiveness of the control environment and providing value added recommendations across the organization. You will gain a robust understanding of the operations of all divisions and functions within the company. Ability to collaborate with a global team of seasoned financial services/audit professionals and access to the latest technological and data analytic tools Competitive compensation package with excellent benefits, including generous paid time off, tuition reimbursement, parental leave and more Advancement opportunities in a global company with presence in 30+ geographies The Team / The Business We have teams made up of people that work effectively together, while working with the larger group of auditors. Opportunities are presented every day to work with people from a wide variety of backgrounds and to develop a close team dynamic with coworkers from around the globe. The Internal Audit function is a global team with presence in all regions (Americas, EMEA and Asia Pacific). The function is independent and reports functioning to the Audit Committee. Responsibilities Lead and perform IT audits focused on compliance with Sarbanes-Oxley (SOX) regulations, ensuring that IT general controls and IT automated controls are effectively designed and operating. Develop, document, and execute test plans for IT controls, ensuring that they meet SOX requirements and are functioning as intended. Utilize GenAI, data analytics and automation tools to enhance audit processes, identify trends, and uncover anomalies in IT systems. Evaluate the SDLC processes to ensure proper controls are in place during system development, implementation, and maintenance. Stay updated on emerging IT risks and controls, including cloud computing, cybersecurity threats, and data privacy regulations. Participate in projects across the internal audit department, including risk-based audits and project assurance initiatives, to enhance overall audit effectiveness and efficiency. What Were Looking For You will be an effective communicator, in both verbal and written form, and an analytical thinker who employs logic and persuasion to influence with diplomacy and tact. You will be a proactive, innovative, collegial team player who can be accountable and absorb/integrate ideas from diverse views, create partnerships and collaborate with others. You will be nimble in learning and support the implementation of agile techniques. You will be responsible for balancing stakeholders and building/fostering relationships with stakeholders. You have a strong interest to learn, embrace agile auditing techniques, adoption of data analytics and emerging tools to strengthen quality of audit execution and SOX controls testing. Basic Qualifications: The ideal candidate must be an experienced audit professional with skills in IT SOX, internal audit, or related roles in control function organizations. Experience/exposure with different data analytics tools (such as Tableau, Alteryx, Power BI, etc.). Agility to support different Internal Audit capabilities such as business/data/IT auditing and SOX compliance. Minimum 3-5 years of relevant experience of IT controls-based testing through planning audits, conducting audit procedures, and preparing audit reports. Understanding and operational application of Sarbanes-Oxley Section 404 Public Accounting experience. Knowledge of or experience with providing audit support during integrated financial and operational audits. Knowledge or experience with information security controls. Experience with electronic work papers and standard productivity tools Bachelor's or Master's degree in Computer Science, Engineering, Information Technology, or a related field. Willing to travel (domestic and international), limited to 10 - 15% Professional certifications preferred but not required (CISA, CIA, CPA, etc.). #L1-RS2 Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. ----------------------------------------------------------- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ----------------------------------------------------------- 203 - Entry Professional (EEO Job Group) (inactive), 20 - Professional (EEO-2 Job Categories-United States of America), FINANC202.1 - Middle Professional Tier I (EEO Job Group)

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

Job details: Role: Sr. Member - Corporate Quality Assurance Direct Reporting: Sr. Expert - Corporate Quality Assurance Level: MD 6 Function: Quality Location: Pune - Hinjewadi Phase 2 Job Purpose and Scope Responsible for implementing the activities for the management of CQA Accountabilities Indicator: CQP Management FSSAI Facility Licensing of Food Business in FOSCOS System. Regulatory Gap analysis and interpretation of Nutraceuticals. Regulatory Compliance for 21 CFR, FSANZ, EU, US and ROW Regulations and Standards for Food and Nutraceutical. Quality and Food Safety Key Accountabilities: Regulatory Assessment: Responsible for Regulatory Compliance check for food/ Nutraceutical industry and perform Gap identification for US, EU and ROW market. To perform GAP identification in Nutraceutical industry for updated Food safety regulation for various market. Liasoning with internal and external stakeholders on implementation and development of regulatory notification and supporting cross functions with their queries related to regulations for various market related to food/ Nutraceutical market. Provide technical review of data or report that will be incorporated into regulatory Submission. FSSAI and related Activity: Coordinating with FSSAI authorities/ Consultancy related to FSSAI compliances, license renewal and modification or any FSSAI updates or resolving queries, etc. Responsible for FSSAI Facility Licensing of Food Business in FOSCOS System. CQP Management Requirement for Food Business Ensure that the sites are ready for enabling audits and compliances. Qualification,Experience & Skills Education: Graduate/ postgraduate in pharmacy/ chemistry/ food tech with regulatory exposure. Experience: 2-4 years of work experience in the field of Quality Assurance of Pharmaceutical /Food Industry. Skills & Competencies: Awareness of regulatory requirements Communications skills Problem solving Exposure to regulatory audits like USFDA/ MHRA etc and certifications like BRC/ FSSC etc

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Supervision & Control Managing Team Brand growth Prescription Growth Prescribers growth Market Share Ensuring ROI Development of subordinates Relationships around the role Reporting to (Business) Zonal Sales Manager Reporting to (Matrix) NA No of Reportees Direct 4-5 Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, Institutional administrators Key Internal Stakeholder(s) Superiors, Subordinates , PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Proven Leadership qualities Good communicator Proven track records Ambitious Behavioral Analytical ability

Supriya life science ltd is looking for Manufacturing Officer to join our dynamic team and embark on a rewarding career journey. Production Management : Oversee the entire production process, including scheduling, resource allocation, and production planning. Quality Control : Implement quality control measures to ensure products meet established standards and specifications. Process Optimization : Continuously assess and improve manufacturing processes for efficiency, cost reduction, and waste minimization. Inventory Management : Manage raw materials, work - in - progress, and finished goods inventory to ensure smooth production flow and prevent shortages or overstocking. Safety Compliance : Ensure that manufacturing operations comply with safety regulations and implement safety protocols to protect workers and equipment. Equipment Maintenance : Oversee equipment maintenance, repair, and calibration to ensure proper functioning and minimize downtime. Staff Management : Supervise and manage production staff, providing guidance, training, and performance evaluations. Cost Control : Monitor production costs, identify cost - saving opportunities, and manage the budget for the manufacturing department. Lean Manufacturing : Implement lean manufacturing principles to reduce waste, improve productivity, and enhance overall efficiency. Continuous Improvement : Promote a culture of continuous improvement and innovation within the manufacturing process. Production Scheduling : Develop and manage production schedules to meet demand and delivery deadlines.

We are looking DM RA with leading pharma company in Thane. Experience in Injectable regulatory affairs pre approval & post approval experience is must. Regulatory Submissions New Project Assignment This role involves the assignment and management of new projects for regulatory submissions, playing a pivotal part in the preparation and timely submission of high-quality regulatory documents across the US, EU, UK, and Emerging Markets. The position demands a strong understanding of global regulatory requirements, excellent communication skills, and effective cross-functional collaboration to ensure successful outcomes. Educational Qualifications Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related scientific discipline Diploma in Regulatory Affairs preferred Technical and Professional Expertise Demonstrated experience in regulatory affairs with a focus on submissions for the US, EU, UK, and Emerging Markets Solid understanding of ICH guidelines, ASEAN CTD requirements, and eCTD publishing standards Practical experience in the preparation, review, and submission of regulatory documents Familiarity with Quality by Design (QbD) principles and data trend analysis Experience 5 to 10 years of relevant experience in regulatory affairs Key Personal Attributes Excellent verbal and written communication skills Strong interpersonal and collaboration abilities Capable of working independently and managing multiple projects simultaneously Domain and Functional Competencies In-depth knowledge of international regulations (e.g., FDA, EMA, ICH) Up-to-date with evolving regulatory frameworks and compliance requirements Proficient in compiling,reviewing, and submitting comprehensive regulatory dossiers Ensures completeness, accuracy, and adequacy of all documents required for product approvals

" Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively. The manufacturing location at Mysore is spread over 69 acres and it s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services. JGL s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market. Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18. Kindly refer www.jubilantpharma.com for more information about organization. Scope of the role Scope - This role is responsible for Responsibilities Achievement of set targets. Maintaining set call Average/coverage. Complete use of allotted resources. Increasing prescriber base Focus on target customers. Maintaining call average and customer coverage Increasing PCPM. Timely reporting. Ensuring ROI Relationships around the role Reporting to (Business) Regional Sales Manager / Sr. Regional Sales Manager Reporting to (Matrix) NA No of Reportees Direct NA Indirect NA Key External Stakeholder(s) Doctors, Stockiest, Retailers, CFA staff, Fellow professionals, institutional administrators Key Internal Stakeholder(s) RSM, ZSM, BDM, NSM / SM, PMT, HR & Sales Admin Competencies critical for the role Scientific/ Technical Competencies Proficiency level Convincing ability Presentation Selling Communication Behavioral Analytical ability PR Skills

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Role & responsibilities Injectable Manufacturing & Visual Inspection Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD – Manufacturing / QMS (Senior Officer / Officer / Executive) Experience - 02 to 07 Years Qualification – B. Pharmacy/ M Pharmacy Engineering (Instrumentation / Process Equipment Maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification – BE / B Tech Time and Venue : 14th June 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. *Having relevant qualification only can attend the scheduled walk-in.

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form PURPOSE AND SCOPE: Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to market new or existing licensed pharmaceuticals products in the domestic and international markets as assigned. Maintains systems designed to ensure compliance with electronic submission requirements and document management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and operational processes, ensuring alignment with evolving regulatory requirements, internal standards, and best practices. . PRINCIPAL DUTIES AND RESPONSIBILITIES: Serves as a seasoned regulatory operations professional with a comprehensive understanding of global submission requirements and processes; applies creative problem-solving to resolve a wide range of technical and operational issues. Manages the end-to-end preparation, compilation, publishing, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards. Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the U.S., Canada, EU, and Asia-Pacific. Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards. Collaborates cross-functionally with Regulatory Affairs, CMC, Medical Writing, Quality, and other stakeholders to ensure timely and accurate handoff of components for inclusion in submissions. Interprets and applies key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, etc.). Leads and contributes to the development, revision, implementation, and training of departmental SOPs, WIs, and standardized publishing processes to ensure consistency, efficiency, and regulatory compliance. Assists in the management and continuous improvement of templates, procedures, and tools used to support global submission activities. Troubleshoots technical issues related to publishing tools and document formatting, particularly within MS Word and Adobe Acrobat, and supports resolution of validation errors. Participates in evaluating and implementing new regulatory technologies; ensures alignment with infrastructure standards and supports transitions from legacy systems to electronic platforms. Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs. May mentor junior staff, provide publishing guidance, and act as a resource for complex submissions. Demonstrates strong organizational and time management skills with the ability to manage multiple priorities under tight deadlines. Ensures compliance with all applicable regulations, company policies, and the Code of Business Conduct. May escalate complex issues for resolution and assist with additional projects or duties as assigned. Assist with various projects as assigned by a direct supervisor. Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function EXPERIENCE AND REQUIRED SKILLS : Bachelor s Degree required; Advanced Degree desirable Minimum five (5) years of regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. Proven expertise in the preparation, compilation, publishing, and validation of eCTD submissions in support of U.S. (FDA), Canada (Health Canada), EU (EMA, MHRA), and Asia-Pacific (PMDA, TGA, NMPA, etc.) regulatory requirements. In-depth knowledge of electronic publishing tools and Regulatory Information Management (RIM) systems. Proficiency with electronic document management systems (EDMS) and advanced knowledge of document formatting tools, particularly MS Word (template and style management) and Adobe Acrobat (PDF optimization and troubleshooting). Strong understanding of global regulatory submission guidance. Demonstrated experience managing multiple submission projects in parallel, with proven ability to meet tight deadlines and deliver high-quality, technically compliant outputs. Strong organizational skills and meticulous attention to detail; able to identify and resolve issues independently and proactively. Excellent written and verbal communication skills, with the ability to clearly document processes, communicate submission requirements, and collaborate effectively across teams. Experience with electronic submissions, specifically eCTD, required. Strong understanding of document management processes in a regulated pharmaceutical environment. Demonstrated understanding of the drug development process and project management experience is highly preferred. Proven experience in developing, revising, and maintaining departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and internal processes, with a focus on continuous improvement and regulatory compliance. Strong software troubleshooting skills. EOE, disability/veterans

Position will be responsible for QA function. Develop, implement and maintain the Quality Management System (QMS) at Scitara. Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements and establish the training function within Scitara. Key Responsibilities Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements. Responsible for authoring, reviewing and approving Standard Operating Procedures, Work Instructions, Policies, Manuals and Guidance documents for Scitara. Represent Scitara in customer audits, regulatory inspections and certification audits (ISO 27001 and SOC II Type 2). Responsible to ensure education and awareness about audit / inspection readiness in the organization. Impart training on SOPs and regulations. Manage CAPAs and deviations at an organizational level. Ensure that software systems meet regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5). Provide QA oversight for all phases of validation (planning, testing, deployment, and change control). Review and approve validation deliverables (e.g., Validation Plan, Test Plan, Test Scripts, Traceability Matrix, Validation Summary Report). Implementing the data privacy policies and associated processes in Scitara across functional units. Bachelor s or Master s degree in appropriate field of study. IT CSV QA candidate with 08-10 years experience in QA, IT and Computer System validation with some background of Software Development. Expertise in validation principles and validation types, software development best practices, and quality management systems used in the FDA/MHRA/EMA regulated environments is required. Preferably, candidates who have worked / supported Pharma / Life Sciences companies. Desired Skills Knowledge and understanding of GxPs and other governing regulations, both local and international. Understanding of quality systems processes and their implementation.