40 Regulatory Audits Jobs - Page 2

Lead Quality Assurance operations, ensuring compliance with GxP and continuous improvement. Oversee Quality Systems to maintain compliance with regulatory requirements and procedures. Ensure timely execution of Quality Assurance activities, including Change Controls, CAPA, Deviations, OOS, OOT, and Market Complaints. Represent QA during regulatory/customer audits, track compliance plans, and implement corrective actions. Monitor the effectiveness of CAPA programs and ensure accurate implementation. Facilitate batch review and release per regulatory requirements. Investigate and resolve non-conformances, ensuring appropriate corrective and preventive actions. Ensure execution of Annual Product Reviews and escalate recommendations to senior management. Maintain adherence to safety, data integrity, and ethical conduct policies. Oversee in-process Quality Assurance (IPQA) for compliance with shop floor activities. Review and approve key documents across Production, Warehouse, Quality Control, Engineering, R&D, and EHS. Participate in cross-functional meetings, ensuring alignment on quality, compliance, and process improvements. Support sterility assurance programs, media fills, and aseptic process monitoring. Coordinate internal audits and ensure timely resolution of observations. Monitor and enhance aseptic practices in the manufacturing environment. Ensure timely investigation and resolution of customer and market complaints. Provide batch disposition decisions and approve release documentation. Ensure timely submission of required documents to regulatory and cross-functional teams. Prepare and review protocols, procedures, and QMS elements to sustain compliance. Identify training needs for QA team members and conduct required training programs. Lead quality discussions in periodic review meetings, supporting compliance and process improvements. Track and monitor timely closure of deviations, root cause investigations, and CAPA. Ensure timely resolution of queries from customers and third-party review teams. Promote continuous quality improvements through effective cross-functional collaboration. Promptly report and escalate non-conformances or critical quality issues for assessment.

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: Alathur Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: KRSG Plant, Bangalore Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Purpose of the role: Responsible for stability Management Primary Responsibility: Strategic: 1. Ensure 100% compliance to usage of Quality systems. Operational: 1. Adherence of cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice). 2. To have control and ensure the Stability team management. 3. To ensure the stability samples are analyzed and released as per schedule. 4. To ensure none of the stability samples are being crossed the window period. 5. Review of Stability samples in quality control department. 6. Instrument/Equipment qualification Review in Quality control. 7. Preparation and maintenance of quality records and study protocols. 8. Preparation of quality system related, Instrument operation related SOPs, Specification, STPs, URS etc. 9. Coordinate with cross functional teams such as Production, QA, Warehouse, SCM etc. 10. Review of method transfer and method validation in quality control. 11. Handling of QMS elements related to quality control. 12. Maintenance and calibration of instruments in Quality control. 13. Quality Interface in audits (both internal and external) and ensure appropriate QMS document identified in a timely manner and closed out. 14. Analysis of vendor samples and reporting. 15. Follow approved STPs, SOPs, and Specifications 16. To ensure readiness for Customer and regulatory audits. 17. Providing the support to meet the management objectives of product deliveries on time in line with Quality Management system. 18. Support quality related activities in other sites of Stelis (as required)

Job Title: Manager-Plant Maintenance Block A Position: Manager-2 Job Grade: G11A No. of Direct Reports (if any): 09 Function: Engineering & Projects. Location: Dadra Areas of Responsibility 1. To ensure 100% Maintenance of all Plant Machinery process Equipments (Granulation equipments-FBD, FBE, RMG, Blender, Tablet compression machine, Tablet Coating machines, Blistering machine, Cartonating machines, Packing Bottle machines, Inspection machine etc.) & its relevant. Ensure minimum time for the breakdown to be achieved 2. To ensure technician & staff deputed at breakdown, preventive & building maintenance works accordingly as per approved shift schedule. 3. To ensure the timely completion of the work orders, purchase orders & purchase requisition & ensure the work measurements are proper and timely bill booking & approval from the Block Head. 4. To involve & support in the modification/ongoing CAPEX as well as projects works for the right implementation of the equipment to ensure right & easy maintenance of the same in future. 5. To ensure the services vendor at site & loading/unloading, fabrication & civil works are carried out as per the GMP norms with safety norms also. AMC if any should be inline as per schedule. 6. To train the people & people management & ensure all have to trained in LMS system as well as applicable OJT in place as per the requirements. 7. To ensure Preventive maintenance & Breakdown maintenance program through SAP system. All records & schedule should be traceable as per SOP. 8. To handle all the stakeholders for their works & timely maintenance solution to each with defined timeline. 9. To coordinate with EHS Department for statuary complies & ensure the safety maintenance. 10. To ensure the critical spares/inventory/hardwares to be available for the maintenance purpose. 24x7 shift management & availability of the manpower’s for the maintenance & rectification works. 11. Implementation of Good Engineering Practices, Good Manufacturing Practices, Data integrity and Good Documentation Practices should be followed & no any noncompliance. 12. To Co-ordinate the internal engineering cross function section like utility, calibration & water system for getting the rectification & timely works completion relevant to process equipment/APU. 13. To prepare the investigation, root cause identification and derive CAPA in case of incident of system failures/out of specification observation and request change control, action item through Track wise (QMS) system. 14. Handling of EDMS, LMS, track wise accordingly & input to be done for the smooth system handling & documents handling accordingly. 15. Co-ordinate for the self-inspection/visit/audit at site & ensure proper walkout for the same while inside the premises/ process equipment area. 16. To handle observations & ensure timely compliances of observations/points same within timeline. 17. To handle the vendor/OEM as per requirements & ensure the GMP compliances accordingly. 18. To ensure all required drawings/layouts of AUTO CAD generated & approved . Status label, record shall be in place & current updated version of the SOP. Drawings/layouts regarding plant equipment & APU system Job Scope Internal Interactions (within the organization) All departments stakeholders External Interactions (outside the organization) External service vendor like fabrication, building maintenance vendors etc. Geographical Scope Any. Financial Accountability (cost/revenue with exclusive authority) To run the maintenance as per defined budget & control the inventory Job Requirements Educational Qualification B.E. Electrical (Preferably). Specific Certification Should know AUTO CAD, PCS system knowledge & Projects skills will add advantages. Skills Good trainer on SOPs, Good mentor to technical staff Experience 10-15 Years.

• Responsible for Regulatory filings for APIs and Intermediates and achieving registrations-DMF (US, Europe, Australia, Korea, Japan, WHO, other reg / non reg countries), CEPs. • Responsible for coordination of all Regulatory Query responses with agencies, regulatory related query responses with customers. • Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. • Life cycle management of DMFs, Registrations -Annual reports, change updations • Support during regulatory audits. • Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc • Review of supplier documentation for regulatory requirements

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across OSD and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)

Role & responsibilities 1. Independently handling of API Sterile manufacturing operations and leading the Team 2. Responsible for Production planning, execution and on-time deliveries 3. Enhancement of Productivity, Yield improvement and Quality improvement 4. Handling of QMS activities 5. Ensure Safe operations of the plant 6. Handling of Customer & Regulatory audits (FDA) Preferred candidate profile MSc/B Tech Chemical with 10 to 20 years experience in Sterile API Manufacturing operations as Lead Role ( Manager/Sr. Manager level) Perks and benefits As per Company norms

Role & responsibilities Plan and execute audit engagements, including data analysis and testing. Review financial statements and supporting documentation. Evaluate internal control systems and ensure adherence to applicable Indian laws. Perform risk assessments and internal control evaluations and detect discrepancies. Identify and investigate potentially fraudulent activities or financial irregularities. Prepare and present audit reports to stakeholders and shareholders. Collaborate with external auditors during statutory audits and regulatory compliance assessments. Monitor the implementation of audit recommendations and execute remedial actions. Stay updated with the latest industry regulations and best practices in internal auditing. Required skills and qualifications Professional certification - CA (Chartered Accountant). 10/12+ years of experience in internal auditing or related financial roles. Strong understanding of Indian accounting standards, taxation and regulatory requirements. Experience in developing and executing audit plans and evaluating internal control systems. Proficiency in preparing and reviewing financial documents and audit reports. Strong communication and interpersonal skills to effectively collaborate with stakeholders at all levels. Excellent analytical, problem-solving and critical-thinking skills. Ability to work independently or in a team. Working knowledge of MS Office applications (Excel, Word, Outlook). Excellent verbal and written communication skills. Strong ethical standards and a commitment to maintaining confidentiality. Ability to adapt to changing regulatory environments and industry practices.

Hi, We are having an opening for Manager- Quality Informatics in our IT department at Halol location. Job Summary : Quality Control GxP Systems - Chromatographic & Non chromatographic systems, Data backup, User management, system software trouble shoot (L1), Computer system validation, Regulatory & Customer audits and compliance, QMS related IT (like Change control, Deviation, Investigation) etc. Areas Of Responsibility : Perform in-house software validation, re-validation of computerized systems of QC Lab and Micro area. Initiate and prepare active user list for Laboratory systems & Perform periodic access right and security policy review for Laboratory systems. Implementation of security policies as per site and global procedure. Perform administration activities as per procedure for computerized systems and instruments. Preparation of data backup and restoration procedures. Execution of manual backup and restoration in lab applications as per procedure. Coordinate with Corporate QA IT and QA department for implementation of Global Procedure. Prepare the SOP/CSAP for Lab computerized systems. Updation of roles and privileges as per business owner requirements and to perform validation related activity. Support Infra-IT activities. Authorized to review/ Signoff the documents related to the Quality informatics systems. Knowledge of Empower, Chromeleon, LABX, ICDAS, Lab Solutions. To perform QMS related activity. Educational Qualification : Diploma IT, BE IT, Computer Science Experience : 12 + Years

Role & responsibilities 1. All Licenses, Labels, Products, PM etc. to comply with FSSAI, LMA, PCB regulations for all 3 plants. Represent CF on regulatory forums. Legal notices closure. Regulatory document filing, tracking and completion for all 3 plants 2. Tracking, CAPA, Complaint resolution communication to relevant stakeholders, Timely resolution/closure of quality related customer complaints 3. Giving regulatory inputs for all NPD/NPI for Label, Ingredients and PM compliance. 100% compliance on all Labels 4. Creating and conducting various Food safety trainings according to BRC requirement to all employees. Food Regulatory training module preparation and training for quality and other relevant stake-holders. 5. Complete at least 3 regulatory related trainings. Preferred candidate profile 5-10 years in Quality Assurance, with 2+ years in a managerial role . Degree in Food Tech, Microbiology, Engineering, or related field . Strong knowledge of QMS, audits, risk management, and compliance . Regulatory & Compliance Process Management Knowledge on Licenses, Factory Compliances Perks and benefits Gratuity Group Mediclaim Policy Group Accidental Policy Performance based Incentives

Responsibilities: - Define, implement and manage operational processes as per regulatory framework to ensure exchange compliance. - Vendor management. - Able to build and manage teams for important functions like account opening, payin payout stock and funds, DP account, customer modification, RMS etc. - Responsible for customer support and seamless experience in a stock broking business. - Ensure process oriented, TAT driven customer support as per defined SOP. - Mentor and monitor team to ensure high level of accuracy and timely execution. - Coordinate with IT and Sales team for development of online customer support process and Process automations. - Handling regulatory audits of SEBI, Exchanges, etc. Candidate Requirement CA/ MBA Finance from good institute 10 - 15 years of Experience in stock broking operations Knowledge of back office software like LD and CDSL Well verse with DKYC process and other broking norms

DRA Manager Experience- 15+ years Salary Package- 13-17 LPA Must have experience in regulatory Countries dossier preparation and working Should have worked in Injectable Unit location- Baddi Himachal Pradesh

Roles and Responsibilities Conduct quality control analysis using HPLC, GC, UV, spectrophotometer, sterile techniques, and other relevant methods. Ensure compliance with USFDA, GMP, GLP regulations during regulatory audits. Develop and maintain SOPs for laboratory operations and testing procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Perform stability studies on APIs and finished products as required. Desired Candidate Profile 2-7 years of experience in a pharmaceutical industry setting with expertise in QC analysis. MS/M.Sc(Science) degree in Chemistry or related field; Strong understanding of analytical instruments such as HPLC, GC, UV spectrometer etc., and ability to operate them effectively.

Job Summary: The Compliance Officer will be responsible for ensuring adherence to regulatory requirements, internal policies, and compliance frameworks. The role involves monitoring and evaluating internal processes, coordinating regulatory approvals, and ensuring compliance with guidelines set by the Reserve Bank of India (RBI) and other regulatory bodies. The Compliance Officer will also assist in risk management and business continuity planning to maintain operational integrity. Note: We are NOT looking for Company Secretary profiles. Job Title: Risk & Compliance Officer Location: GIFT City, Gandhinagar, GJ. Department: Compliance Reporting To: Head Compliance & Assurance Key Responsibilities: Regulatory Approvals & Compliance: Ensure all internal and regulatory approvals are in place before seeking Parent Banks approval for new processes/initiatives. Ensure RBI approval is obtained before implementing any new process or initiative. Maintain compliance with all prerequisites stipulated by the regulator. Regulatory and Contractual Compliance: Ensure compliance of Master Service Level Agreements (MSLAs) and Partner Service Level Agreements (PSLAs) with all applicable regulations. Conduct periodic reviews to align policies, Standard Operating Procedures (SOPs), and guidelines with regulatory requirements. Monitoring & Compliance Assessment: Conduct timely test checks on outsourced activities to ensure adherence to internal policies and RBI guidelines. Monitor compliance-related violations, incidents, and investigations, coordinating with relevant internal and external departments for resolution. Facilitate the development and maintenance of a risk management framework by supporting relevant teams in identifying, measuring, and mitigating risks using Key Risk Indicators (KRIs). Audit & Regulatory Reporting: Ensure timely redressal of issues raised by Risk-Based Supervision (RBS), Audit Observations, Zonal Internal Audit Department (ZIAD), Central Internal Audit Department (CIAD), or any other regulatory authority. Assist in the preparation and submission of requisite compliance reports to regulatory authorities and senior management in a timely manner. Support periodic risk assessments and internal audits to maintain regulatory adherence. (Risk Management Dept. to conduct risk assessments) New Business & Product Review: Review new business initiatives and products, collaborating with risk management, control, and business teams to ensure compliance before implementation. Business Continuity & Compliance Support: Facilitate Business Continuity Plan (BCP) drills as per regulatory and internal requirements. Collaborate with Risk Management Department in preparing regular risk management reports for stakeholders, senior management, and the Board. IT Security Governance: Collaborate with senior management to establish and maintain IT security governance frameworks. Monitor adherence to internal IT security policies and procedures. Support the enforcement of access control policies, data protection measures, and secure system configurations. Incident Management: Assist in investigations of security breaches and compliance violations. Support coordination of response actions for IT security incidents and ensure timely reporting to regulatory bodies if required. Recommend corrective and preventive measures post-incident. Key Skills & Competencies: Strong knowledge of RBI regulations and financial compliance frameworks. Excellent analytical and risk assessment skills. Attention to detail with strong problem-solving capabilities. Ability to coordinate and collaborate with cross-functional teams. Strong written and verbal communication skills. Ability to handle regulatory audits and stakeholder expectations effectively. Qualifications & Experience: Bachelors or Masters degree in Finance, Law, Business Administration, or a related field. Minimum 3-5 years of experience in compliance, risk management, or regulatory affairs within the banking or financial sector. Prior experience in handling RBI regulatory requirements and audits is preferred. Professional certifications such as Financial Risk Manager (FRM) would be an advantage Note: The responsibilities outlined above are indicative and may change based on organizational requirements and regulatory updates.