129 Regulatory Audits Jobs

Compliance with SEBI regulations, stock exchange rules Internal Audits & Inspections Reporting & Filings Policy development & implementation Grievance Redressal Training & Awareness Surveillance & Monitoring Coordinate with regulators(NSE,BSE,SEBI)

Role & responsibilities Conduct Transaction Monitoring as per guidelines defined in the Process maps Prepare transaction monitoring reports and ensure timely and accurate reporting Participate in calibration exercises on a regular basis to ensure consistency in measurement. Conduct ongoing analysis of quality performance and recommend actions for improvement at associate / process level Update performance data to ensure timely and accurate reporting of SLAs Work closely with Client Trainer / SME and Operations team to conduct team huddles. Perform transaction processing as per defined policies and procedures Provide feedback to associates based on monitoring results if required. Preferred candidate profile 1. Any Graduate 2. Candidate with minimum 2 years QA experience in BPO Industry.

Role & responsibilities 1. Audit Planning & Execution: Assist in preparing the annual audit plan in line with hospital objectives and risk assessments. Conduct internal audits across departments such as Finance & Accounts, Billing, Pharmacy, Supply Chain, HR, IT, Clinical and Non-clinical operations. Review compliance with statutory requirements (Income Tax, GST, NABH/NABL standards, etc.). Perform surprise audits in critical operational areas (pharmacy, billing counters, cash management, stores, ICU/OT consumables) 2. Risk & Control Assessment: Evaluate internal control systems, identify gaps and suggest process improvements. Analyze financial data, operational processes, and clinical documentation to detect anomalies or risks. Ensure hospital assets (cash, stock, equipment, patient data) are adequately safeguarded. 3. Compliance & Reporting: Verify adherence to hospital policies, procedures, and regulatory guidelines. Prepare audit reports highlighting findings, risks, and actionable recommendations. Present audit observations to the Manager / Head Internal Audit and concerned HODs. Follow-up on implementation of corrective actions. 4. Support & Coordination: Assist in coordinating with stakeholders. Support management in special investigations (fraud, malpractice, revenue leakage). Work with cross-functional teams to streamline processes and strengthen compliance. Preferred candidate profile 1. Strong knowledge of auditing standards, accounting principles, and hospital operations. 2. Proficiency in MS Excel, ERP systems, and data analysis tools. 3. Eye for detail with strong analytical and problem-solving skills. 4. Good communication, report writing, and presentation skills. 5. Ability to work independently and handle multiple assignments. 6. High ethical standards and confidentiality.

Role Overview: As a Manager in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role will be critical in handling in-process Quality Assurance functions. You will ensure that defined and approved IPQA checks are followed and documented during Dispensing, Manufacturing, filling, capping, and Packing stages. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing. Additionally, you will review Smoke study protocol, report, and Video recording, and participate in regulatory audits. Key Responsibilities: - Handle in-process Quality Assurance functions by ensuring compliance with defined IPQA checks during various stages of manufacturing - Ensure compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing - Review Smoke study protocol, report, and Video recording, and authorize final document approval in the absence of Head Quality Assurance - Participate in regulatory audits and ensure compliance - Review and approve Process validation, cleaning validation, aseptic process simulation protocol, reports, change control, deviation, incident reports, OOS, OOT, non-conformance, and CAPA in consultation with Head Quality Assurance Qualifications Required: - M. Pharm/B. Pharm qualification - 15 to 17 years of experience in the pharmaceutical industry - 03 years of experience at Zydus - Knowledge and experience in an injectable plant Please email your CV to isha.naik@zyduslife.com for consideration.,

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 20.09.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D, API R&D Candidates also eligible for this positions Position : Executive / Senior Executive Qualification : M.Sc, M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 20.09.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786

B.Sc/M.Sc Chemistry, 1–8 yrs exp in API/Pharma QC. Must handle HPLC/GC/UV/IR, cGMP, stability, and docs. Local preferred Dahej. Only male candidates are required. Only pharma experience required.

As an experienced candidate with 17-20 years of experience, your role as Engineering Department Manager will involve the following responsibilities: - Manage and lead the engineering department at the site, ensuring smooth operations. - Oversee operation and maintenance of HVAC systems and utilities. - Develop, implement, and monitor monthly planners and maintenance schedules. - Ensure readiness of the department for customer and regulatory audits; represent the department during audits. - Implement corrective and preventive actions (CAPA) and monitor their effectiveness. - Monitor and ensure compliance with process equipment and facility maintenance activities in line with cGMP requirements. - Maintain and control all engineering documentation required for regulatory audits. - Ensure compliance with all statutory and regulatory requirements related to the engineering department. - Manage qualification, validation, and CSV validation activities. - Manage change control, deviations, QRM, and all QMS-related documentation. - Drive implementation of cGMP, GDP, Good Engineering Practices, and Learning Management Systems. - Manage external vendors and contractors with proper work planning, supervision, and monitoring of activities. - Prepare, review, and approve SOPs and engineering drawings. - Prepare and monitor the engineering budget, including expenditure under various budget heads and site projects. - Propose and implement improvement and cost-saving plans for management approval. - Identify departmental training needs, ensure trainings are conducted as per schedule, and oversee allocation of roles, jobs, and responsibilities to team members and contract staff. Desired Skills: - Experience of handling engineering in a reputed pharmaceutical organization. - Hands-on experience in handling Utility (Chiller, air compressor, air dryers, boiler) HVAC. - Experience in handling statutory requirements. - Experience in facing regulatory audits, especially USFDA. - Good technical know-how and exposure to the latest technology and process equipment. - Ability to pivot and try new approaches when faced with challenges. - Very good communication (written and oral), interpersonal and conflict resolution skills. - Leadership, mentoring, and team-building skills. - Ability to work on multiple projects in various stages. - Personnel and project management skills.,

Job Summary Dispatch Achievement Verification of all Inwards & Outward material with correct documents, material code & qty etc. Stock Management Slow & non moving stock management 5s & Kaizan though implementation in ground operation Labor Management SOP compliance Minimum stock planing of Material & Packing material Working Language : - Hindi,Marathi,English

You will be joining BNP Paribas India Solutions as an AVP / VP Financial Control, a supervisory role ensuring the day-to-day operations are conducted with high levels of personal integrity. Your key responsibilities will include: - Drawing up accounts of the Company as per applicable regulations and basis IND AS - Providing ongoing guidance on Financial Accounting to the team - Assisting compliance and tax teams with sharing information related to statutory and regulatory compliance - Contributing to various projects, particularly automation and process improvement initiatives - Managing Nostro Reconciliation and ensuring timely closure of breaks - Ensuring smooth month-end closure and adherence to all Head office reporting requirements as per IFRS - Handling Statutory & other audits and ensuring smooth completion with no major findings - Conducting investigations with due diligence on discrepancies - Preparing the Board presentation quarterly - Attending to routine and ad-hoc data requests from Senior Management Additionally, you will be involved in assisting with monthly closure of books, receivable-related accounting, compliance filings, and preparation of Senior Management Dashboard / Board Packs. You will also contribute by analyzing Revenue/Expenses variance on a monthly basis and assisting in regulatory audits & tax compliances. As a successful candidate, you must possess: - Strong analytical skills, detail orientation, service commitment, solid organizational and interpersonal skills - Ability to work independently and in a team environment, prioritize tasks, and meet deadlines - Proficiency in Microsoft Office Applications, particularly strong MS-Word & Excel skills - Excellent communication skills and ability to manage a stressful work environment - Strong result-oriented and self-driven mindset - Willingness to travel as required due to team split between Chennai and Mumbai Specific qualification required for this role is being a Chartered Accountant (CA) with 12 to 16 years of post-qualification experience in the relevant industry.,

Role & responsibilities Manage regulatory audits and inspections Respond to regulatory queries Internal Audit Report co-ordination and submission Co-ordinate with various depts for data Improve the Compliance framework of the company Responsible for the Internal Audit report preparation and submission Responsible for Off-site, onsite and AP audits and inspections. Regulatory interaction and reporting. Timely submission of IAR Preferred candidate profile Good understanding of MS Office and inter departmental co-ordination Graduate in commerce or law or CS Interested candidates can share theior updated resume on swapnali.mendonca@sharekhan.com

PREFERRED INDUSTRYAPPLY ONLY Immediate Joiners JOB LOCATION: SOUTH GOA, GOA PREFERRED INDUSTRY: Solar, energy efficiency or regulatory sector Job Description: Audit and Compliance Executive Location: South Goa, India (Work from Office) Experience: Minimum 3 years in International process (must) Job Type: Full-time Job Timings: 6am - 3pm IST About Us Cogncise Business Services is a fast-growing business solutions company with expertise across energy efficiency, marketing, and customer engagement. We partner with leading energy providers to help households in Oceania region adopt renewable energy solutions from solar panels and batteries to state-driven energy efficiency upgrades. Position Overview We are seeking a detail-oriented and experienced Audit and Compliance Executive to join our team and ensure adherence to the Program regulations and internal compliance standards. This role is critical in maintaining the integrity of compliance, verifying documentation accuracy, pictures and ensuring compliance with the program guidelines. The successful candidate will play a key role in safeguarding operational efficiency, mitigating compliance risks and supporting audit readiness. Key Responsibilities Audit & Verification Conduct regular audits of installation records, customer consent forms, product specifications and installer details in line with program requirements. Verify creation data against compliance standards and supporting evidence. Maintain and review compliance registers, checklists, and audit trails to ensure accuracy and completeness. Compliance Monitoring Monitor and interpret program regulatory updates, policy changes and compliance guidelines for all the program activities. Ensure all business processes, installations and documentation meet regulatory obligations. Identify risks of non-compliance and proactively recommend corrective actions. Reporting & Documentation Prepare detailed compliance and audit reports for management and external auditors. Document audit findings, recommend process improvements, and follow up on remediation plans. Maintain accurate compliance records for audit purposes and VEEC creation submissions. Skills & Qualifications Bachelors degree in Business, Law, Compliance, Accounting, or related field. Minimum 24 years of experience in compliance, auditing or quality assurance (preferably in the Solar, energy efficiency or regulatory sector). Excellent attention to detail, analytical and problem-solving skills. Strong written and verbal communication skills for preparing audit reports and liaising with stakeholders. Proficiency in MS Office (Excel, Word, Outlook) and compliance management systems. Key Attributes Integrity and ethical judgment in handling compliance matters. Ability to work independently with minimal supervision while collaborating effectively with cross-functional teams. Process-driven mindset with a focus on continuous improvement. Strong organizational skills to manage multiple audits and deadlines. Reporting Line Reports to: Compliance Manager / CFO Join us and play a key role in helping Oceania households move towards a cleaner and greener future. Interested candidates can apply directly on Naukri.com or send their updated CV to hr@cogncise.com.

Core expertise in IPQA, 21 CFR compliance, validation & qualification, E-BMR/E-Log, QMS, risk assessment; skilled in audits, regulatory compliance, team management, training, and digital quality systems. Required Candidate profile B/MPharma 7 - 10 years of experience

JOB DESCRIPTION OF SUPERVISOR GROUND OPERATIONS CONTROL CENTRE (GOCC) JOB PURPOSE The Supervisor in Ground Operations Control Centre will be an integral link between Ground Operations and OCC and is responsible for ensuring the smooth and efficient functioning of ground and freight operations at various airports across India. The individual will oversee compliance with all relevant regulations, manage staff duty rosters, coordinate with airport authorities, and maintain infrastructure at stations. Additionally, the role involves handling charter flights, overseeing regulatory audits, recommending policy revisions, as well as monitoring and managing financial activities, including expenses, invoices, and bills. Carry out the duties and responsibilities as under and also as may be specified by the Company from time to time. 2.0 KEY RESPONSIBILITIES Ensure compliance with DGCA, IATA, ICAO, airport operator regulations, and company procedures. Develop and recommend strategies to enhance service levels at station level; monitor and report operational performance. Manage staff duty rosters across India to ensure proper coverage during all flight and cargo handling stages. Coordinate with Station Managers/Assistant Station Managers to secure parking bays and flight slots. Oversee infrastructure and stationary requirements including operational offices and cargo warehouses at stations. Establish and maintain documentation for regulatory audits by DGCA, AAI, BCAS, and other relevant agencies. Report accidents/incidents, ensure corrective actions are taken by Station Managers/Assistant Station Managers and provide the ATR to Flight Safety. Review and suggest revisions to ground and freight operations policies periodically. Handle and coordinate charter flights, both domestic and international. Coordinate training programs for employees and Ground Handling Agents (GHAs). Monitor competitor activities, market trends, compile cargo-related statistics, provide feedback, and recommend sales policies. Manage and monitor overall ground and freight operations and coordinate with OCC and other stake holders. Monitor and manage all expenses, invoices, and bills from ground operations; check, verify, and submit to accounts for timely payment and recovery if applicable. Maintain and monitor the Ground Operations budget and contracts. 3.0 SAFETY ACCOUNTABILITIES Intervene to prevent unsafe conditions developing. Reporting potential hazards. Reporting incidents, accidents and near misses. Being aware of human factors and human factor limitations. Promoting the Company&aposs Safety Management, Quality and HSE Policies. Familiarising themselves with the Safety Management System. Familiarising themselves with the information available in respect of hazards, equipment, procedures and processes relevant to their tasks. Identifying quality and safety improvements. Cooperating with audits and investigations. 4.0 GENERAL COMPETENCE & CONDUCT Demonstrate thorough understanding of daily operational processes, systems, and SOPs. Ensure effective shift handovers and conduct self-audits during each duty period. Maintain coordination with internal departments such as Engineering, Ground Operations, and Commercial. Attend all mandatory training, meetings, and refreshers on time. Comply with company HR, communication, and conduct policies. 5.0 BUDGET CONTROL Participate actively in the preparation of the annual departmental budget for approval by the Head of Department. Develop and maintain an efficient and comprehensive budgeting process aligned with company goals and objectives. Promote and maintain a strong cost-awareness culture within the department. Monitor budget performance regularly, identify variances, and recommend corrective actions or cost-saving measures. Prepare accurate and timely financial reports (including budget vs. actuals) to support decision-making. Ensure all expenditures remain strictly within approved budgetary allocations. Show more Show less

Exp. in IPQA, line clearance & digital documentation w/ E-BMR & E-Log. Equipment qualification & process validation, w/ an understanding of 21 CFR Pt. 11 & audits. Risk assessment, CAPA management & conducting internal & vendor audits. Tech Transfer Required Candidate profile 10-15 Yrs B. Pharma / M. Pharma

Exp. in IPQA, line clearance & digital documentation w/ E-BMR & E-Log. Equipment qualification & process validation, w/ an understanding of 21 CFR Pt. 11 & audits. Risk assessment, CAPA management & conducting internal & vendor audits. Tech Transfer Required Candidate profile 10-15 Yrs B. Pharma / M. Pharma

As a Senior Manager 2 in the Global Quality CMO department at Sun Pharmaceutical Industries Ltd, your primary responsibility will be to ensure that SUN Pharma Quality and Compliance Standards, along with global regulatory authorities requirements, are consistently met across all SUN affiliates, CMOs, Suppliers, and SUN sites/Operational Units. Your role will involve providing Quality Oversight, conducting Independent auditing, and implementing necessary Follow-up actions to achieve, maintain, and enhance the desired level of compliance. Your essential job functions will include participating in the evaluation of Contract Manufacturing Organizations (CMOs), overseeing and approving various Quality Management System (QMS) elements reported by CMOs, reviewing and approving master documents like Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) from CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, reviewing and maintaining quality agreements with CMOs, initiating QMS documents, monitoring activities at CMO sites, reviewing executed documents related to SUN Products, performing batch release of SUN products, conducting visits to CMO sites, preparing visit reports, ensuring preparedness for Regulatory Agency Inspections, participating in product release audits, preparing monthly reports, participating in trainings, following Corporate Quality Policies/Global Quality Standards, executing project work, and performing risk assessments. To qualify for this role, you should hold a degree in M.Sc./B. Pharm/M. Pharm or equivalent, along with 15-18 years of total industrial experience. Experience in CMO and working knowledge with Regulatory markets would be highly beneficial for this position. If you are passionate about ensuring compliance with quality standards, regulatory requirements, and enhancing overall quality management processes in a pharmaceutical setting, this role as a Senior Manager 2 in the Global Quality CMO department at Sun Pharmaceutical Industries Ltd could be the perfect opportunity for you.,

The position of Sr. Manager Supply Chain Management will entail leading the end-to-end supply chain function for the Primary Pharma Packaging Plant located in Gonde Nashik. Your responsibilities will include ensuring uninterrupted availability of raw materials, consumables, and services in compliance with stringent pharmaceutical industry standards. To excel in this role, you must possess expertise in Procurement, Stores, Logistics, Inventory Management, Vendor Development, and Materials Planning, with a keen focus on cost efficiency, timely availability, and compliance with CGMP, FDA, and regulatory standards. Effective coordination across functions is also a key aspect of this position. In the realm of Procurement / Purchase Management, you will be required to develop sourcing strategies for various materials used in pharma packaging, ensuring adherence to pharma regulatory norms. Negotiating and finalizing supply agreements to guarantee the best quality, cost, and delivery timelines will be crucial. Collaboration with the Quality Assurance (QA) team to implement efficient supplier quality management systems will also fall under your purview. Overseeing Stores & Inventory Management will involve ensuring safe and compliant handling, storage, and retrieval of materials, along with maintaining accurate stock levels to prevent shortages or overstocking. Upholding FIFO/FEFO practices, batch traceability, and storage in line with regulatory requirements will be essential, along with coordinating with QA for material approval, quarantine, and release. In the domain of Logistics & Distribution, you will be responsible for planning and controlling inbound and outbound logistics, managing transporter networks, and ensuring compliance with pharma transport norms and documentation requirements. Handling export logistics, customs clearance, and statutory compliance for global clients will also be part of your responsibilities. Your role will also encompass Planning & Coordination, where aligning the supply chain strategy with various functions such as Production, QA, QC, R&D, and Sales is pivotal. Developing Material Requirement Planning, maintaining optimum inventory levels, and preparing MIS reports to highlight key performance indicators will be crucial tasks. Vendor Development & Management will require you to identify and develop compliant vendors, conduct audits, drive cost reduction initiatives, and ensure suppliers adhere to pharma industry standards. Desired qualifications for this role include a graduate degree in Engineering / Science / Commerce with an MBA / PGDM in Supply Chain Management / Materials Management preferred. A minimum of 10-12 years of experience in Supply Chain / Purchase, with at least 5-7 years in a leadership role within the Pharma Packaging / Pharma Industry, is preferred. Key Skills & Competencies that are essential for this role include strong expertise in Procurement & Supply Chain Management within the pharma packaging industry, knowledge of regulatory norms, proficiency in SAP system, strong vendor management and negotiation skills, and leadership qualities to manage cross-functional teams effectively. Success in this position will be measured by key performance indicators such as on-time material availability, procurement cost savings, inventory accuracy, vendor compliance, logistics cost optimization, and team capability development. The ideal candidate for this role is a seasoned Supply Chain professional with 10-15 years of experience in procurement, stores, inventory, logistics, and vendor management, preferably within the pharma packaging or regulated pharmaceutical industry. They should possess hands-on expertise in SAP (MM/WM modules), a proven track record in handling regulatory audits, and a strong focus on maintaining compliance standards while driving cost optimization. Mandatory Skills Required for this role include expertise in Pharma Packaging, Regulatory Audits, Regulatory Standards, SAP System, Supply Chain Management, Vendor Compliance, Vendor Development, Vendor Management, Procurement, SAP knowledge, logistics optimization, analytical capability, and leadership qualities.,

Job Requirements Role/ Job Title: Senior Specialist-IT Governance & Compliance (IT Compliance & Risk Specialist) Function/ Department: Information Technology Job Purpose The role entails the responsibility to be a part of IT Governance and Compliance Team of the bank and would be working towards GRC control function: Compliance & Regulatory reporting viz Cyber KRI, TRANCHE, ICAAP etc. Roles & Responsibilities Custodian of IT governance and IT process governance framework. Handling of Regulatory audits and submissions. To understand Indents from regulators, collated, review the data and timely submission. Responsible for IT policy creation, review, update, awareness, and monitoring. Administration of key IT processes: E.g., incident management, policy exception management Will be reporting to Lead IT Governance. Identify improvements and breakdowns in IT governance elements with significant business impact. Create and maintain library of governance artifacts and other supporting documentation. Proactively identify and manage risks/issues, ensure proper visibility and communication occur to senior management. Ensures compliance with all policies and procedures in the execution of technology projects. Provide guidance and trainings to Project team members in the field regarding IT governance. Capture and share best- practice knowledge amongst the team. Create an environment that promotes collaborative learning and collective ownership of responsibilities. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Ability to work independently and collaborate effectively in a team environment. Education Qualification (Fulltime) Graduation: Bachelor of Technology B.Tech, Bachelor of Computer Applications - BCA, Bachelor of Engineering - BE, Bachelor of Science - B.Sc Post-graduation: Master of Technology M.Tech, Master of Computer Applications - MCA, Master of Business Administration - MBA, Master of Science - M.Sc Preferred Certifications: CISA, CISM, CISSP, CRISC, or equivalent are preferred. Experience Minimum of 8+ Years in IT Compliance, Regulatory reporting and KRI Submissions. Show more Show less

As a Pharma Subject Matter Expert (SME) Trainer, you will be responsible for training candidates in various aspects of Quality Control (QC), Cell Culture Techniques, and Laboratory Procedures. Your role involves providing hands-on experience in analytical testing, microbiological testing, and pharmaceutical laboratory operations. It is essential to educate candidates on method validation, stability testing, and data integrity while ensuring compliance with FDA, USP, and cGMP regulations. Additionally, you will train individuals in utilizing HPLC, GC, UV-Vis, FTIR, PCR, ELISA, and Spectroscopy techniques. Your responsibilities include conducting mock interviews, assisting with resume preparation, and providing real-world project training to enhance the skills of the candidates. You will be required to ensure that trainees understand deviation handling, OOS/OOT investigations, CAPA processes, and regulatory audit procedures. Collaboration with the sales team is crucial to ensure that the trainees meet the expectations of their future employers. The ideal candidate should possess hands-on experience in cell culture, microbiology, and analytical laboratory techniques. Proficiency in HPLC, GC, FTIR, UV-Vis, and PCR is essential for this role. A strong understanding of data integrity, compliance documentation, and industry regulations such as cGMP, ICH, USP, and FDA guidelines is also required. Previous experience in stability testing, method validation, and impurity profiling will be beneficial. Your excellent mentoring and training skills, coupled with a passion for upskilling candidates, will be key to your success in this position. In addition to the specific responsibilities mentioned above, you will be expected to conduct one-on-one in-person training sessions, coordinate with internal teams for seamless training execution, and provide support to candidates in resume building, interview preparation, and exposure to real-time projects. Keeping abreast of industry trends and continuously updating training content accordingly is an integral part of this role. Please note that candidates who successfully complete two years with us will be eligible for visa sponsorship. If you are enthusiastic about mentoring and developing future pharmaceutical professionals, we look forward to receiving your application.,

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufacturing , preferably at the level of Assistant Manager or Senior Executive , and demonstrate a proactive approach with a strong commitment to quality and compliance. Responsibilities: Lead QMS planning and implementation to ensure regulatory compliance and adherence to Acharya Group standards. Review and approve SOPs for Quality Management Systems, ensuring clarity and best practices in API manufacturing. Oversee document control for SOPs and BPCRs, maintaining accurate records. Train plant employees on quality procedures specific to API production. Review annual trending of products and intermediates to verify process and quality system consistency. Assist in implementing cGMP guidelines across the Acharya Group. Conduct validations (Process, Analytical Method, Cleaning) as per the Validation Master Plan for robust API manufacturing. Establish and maintain equipment calibration and validation procedures. Conduct vendor and internal audits to assess compliance and identify areas for improvement in the API supply chain. Ensure thorough investigation, resolution, and documentation of critical deviations, implementing effective CAPA measures. Conduct vendor and internal audits to assess compliance and identify opportunities for improvement within the API supply chain. Manage material and vendor quality, including handling audits by USFDA, EDQM, and customer audits. Review batch production and laboratory control records before releasing APIs and intermediates. Perform periodic product quality reviews and conduct quality risk analysis for continuous improvement of API manufacturing. General Expectations and Past Experiences: Possess a strong understanding of cGMP regulations and guidelines related to API manufacturing. Demonstrated experience in managing and leading quality assurance activities in a pharmaceutical setting. Proven ability to conduct and manage process validation, analytical method validation, and cleaning validation. Experience in preparing and reviewing regulatory documents such as DMF/ASMF. Proficient in using Quality Risk Management (QRM) tools and techniques. Excellent technical writing and documentation skills. Strong leadership and communication skills, with the ability to effectively interact with cross-functional teams and regulatory agencies.

Coordinate technology transfer activities for (OSD) formulations from R&D to manufacturing sites, Support scale-up, exhibit, and validation batches, participate in investigations, deviation handling, and change control activities.

Lead end-to-end tech transfer of OSD products from R&D to commercial manufacturing sites, conduct scale-up and process validation activities, and provide technical support during regulatory audits and inspections.

Hi, Greetings from Avani Consulting . We are hiring for the below opportunity: Company: A leading Pharmaceutical API Unit Designation: Associate Engineering maintenance Process, WTP Experience: 3-5 year in API-Pharmaceutical Qualification: Diploma / BE in Mechanical Engineering Department: Engineering Location: Mysore Package 5-7 Lakh Roles & Responsibility: 1. Candidate should have Experience in Maintenance of Process equipments like Glass lined, SS Reactors, ANFD (Agitated Nutche filter & driers), RCVD, hot water system, Sifter, multi mill, Different process pumps like centrifugal, positive displacement with single and double mechanical seals etc. 2. Hands on experience in pumps, agitator mechanical seal, bearing replacement, troubleshooting, alignment etc. 3. Candidate should have the experience in operation and maintenance of Water system (both Potable water system & Purified water system) 4. Experience in execution of line modification as per the requirement. 5. Preparation & Execution of Process Equipment qualification documents like URS, DQ, IQ and OQ. 6. Carryout the Preventive maintenance for all the equipment’s as per the schedule and maintaining Report & Planner. 7. Coordination with cross functional teams for preparation of documents and reports etc. 8. Spare planning, procurement, BOQ etc. 9. Candidate should have experience in Safety work permit system and documents 10. Candidate should have knowledge on as built P&ID, Equipment layout & facility layout for documentation and qualification 11. Added advantage if candidate faced any audits (Customer/ Regulatory), have Experience in API- Pharmaceutical industries and regulatory guideline such as ISO, USP and WHO. Thanks & Regards Priyanka [ 9518220852 || priyanka@avaniconsulting ]

4+ Yrs of exp in Compliance audits,User Access Reviews,Data Analysis. Reviewing Access logs, Identifying discrepancies, Collaborating with DT & CDR teams to rectify access related issues. proficiency in data management & access management tools.

Job Description Manager / Sr. Manager (Contract Manufacturing & Quality Compliance) Location: Pune Department: Manufacturing & Quality Reports To: Head – Operations / Quality Role Overview We are seeking an experienced and proactive professional to manage and coordinate production activities at contract manufacturing sites. The ideal candidate will have strong expertise in production planning, quality systems, regulatory compliance, and cross-functional collaboration to ensure timely supply of high-quality products in alignment with business objectives and global regulatory expectations. Key Responsibilities Production & Planning Manage and oversee production planning at contract manufacturing sites to achieve productivity and supply targets. Collaborate with internal teams and CMOs (Contract Manufacturing Organizations) for on-time execution of manufacturing schedules. Quality & Compliance Establish, monitor, and enhance quality systems at contract sites ensuring adherence to cGMP and international regulatory requirements. Promote a culture of quality and compliance across partner sites, ensuring readiness for export market audits. Review batch manufacturing records and ensure product quality in line with cGMP guidelines. Oversee shop-floor compliance, reviewing incidents, deviations, and change controls for timely closure. Drive resolution of quality audit observations, market complaints, and CAPA implementation. Ensure robust quality systems that deliver zero critical/major complaints. Technology Transfer & New Products Coordinate with technology transfer teams for new product introductions and product transfers to CMOs. Support smooth and timely execution of technology transfer activities to meet market and business requirements. Training & Capability Development Conduct training programs to upskill site teams and ensure preparedness for regulatory inspections. Process Improvement & Cost Optimization Identify and implement continuous improvement opportunities for efficiency, process optimization, and cost reduction at CMO sites. Vendor & Market Engagement Engage with vendors, industry stakeholders, and potential third-party manufacturers to strengthen the vendor network and ensure future scalability. Desired Candidate Profile Education: B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or related discipline. Experience: 8 - 10 years in pharmaceutical manufacturing, quality assurance, or contract manufacturing operations. Strong knowledge of cGMP and global regulatory guidelines (USFDA, EMA, MHRA, etc.). Proven experience in managing contract manufacturing sites and handling regulatory audits. Exposure to technology transfer, process improvement, and vendor management. Demonstrated leadership, communication, and problem-solving abilities. Key Competencies Excellent knowledge of pharmaceutical production and quality systems. Strong project management and coordination skills. Ability to manage multiple stakeholders and vendors effectively. Analytical mindset with a balance of compliance and cost optimization. Commitment to fostering a strong culture of quality and compliance.