331 Usfda Jobs - Page 7

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

: - Excellent knowledge of products Manufacturing of Colour Cosmetics personal care, Skincare, Cream, Shampoo, Hair Oil, Conditioner, Face Wash, Body Wash, Body Lotion and Foot Care ,Lipstick, Nail Polish Etc. Lay down procedure to implement GMP & GLP norms and ensure documentation & compliance Define AQL for incoming raw material and components Develop vendor base to meet cost, quality (manufacturing and product), and innovation requirements Development of new formulation as per the business demand Preparation of documents & Registration of product, label compliance with regulatory authorities - local & overseas. Skills :- Must come from the personal care background. Worked for the majority of their career in the development of formulations for personal care products. Familiar with cosmetics compliance requirements for EU, US FDA. Ready and able to work on multiple product formulations at the same time, with a view to develop potentially new products.

We are seeking a skilled Analyst with hands-on experience in FTIR/Disso/UV/KF/HPLC/GC techniques(Multiple requirements). The candidate should be well versed with Method Development, Method Validation and routine analysis. Required Candidate profile It is on the rolls of Cotecna Life Sciences India Pvt Ltd(Erstwhile Geochem Laboratories) If interested please share profiles on nilesh.kadam@geochem.net.in or any more information call on 9870476784

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 Responsibilities Qualifications 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

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

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.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

: 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.

: Job Title Regulatory Filtering Analyst LocationJaipur, India Role Description Regulatory Operations is responsible for defining and implementing procedures which provide regulatory operations services for various divisions of the bank and its group entities. This is to support the bank in its efforts to ensure regulatory compliance. Work includes: Partnering with the banks regulatory team to translate regulation into operational processes/procedures assisted Developing the banks information technology infrastructure Developing and implementing regulatory strategies, procedures and controls for new products and/or business activities that require governmental approvals Preparing and submitting regulatory applications such as permits, licenses, certificates and authorization required by governmental agencies Coordinating government interactions and compliance activities; and interacts with regulatory agencies 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 Support the RTB team lead in protecting DB from legal, regulatory and reputational risk with regard to business involving sanctioned entities and / or countries. Ensure diligent review and confirmation of transactions that require escalation to a Level 2 investigator and decide on these in full compliance with the applicable Sanctions regulations and the banks policies and procedures. Execute internal control checks as defined in the KOP documentation and Embargo control framework documents governed by AFC Sanction & Embargo. Support any applicable reporting obligations to the competent authorities with respect to transaction handling. Convert timely the update of the relevant embargo lists in respective filtering systems implement the data to central and decentralized tools in GT and Operations. Support CoC Regulatory Filtering team on the adoption of new clients Your Key Accountabilities RTB focus Primarily review stopped messages and take a decision on them (either pass or investigate), based on limited set of rules provided and maintained by AFC. Record rationale for decision from pre-defined set of options. Seek feedback from more senior investigators/reviewers, where their decisions fail the four-eye control. Provide support feedback loop and filter optimization by identifying repeat mismatches to propose Good Guys. Use user access privileges only for authorised purposes; actively safeguard sensitive and confidential information. CTB focus Supports TSMO / AFC related change projects Supports remediation actions owned by TSMO / AFC Training & Development Participate Trainings such as on HotScan, Sanctions policies, L1 procedures, specific payment types, including structure / form of messages. Your skills and experience Sanctions and Regulatory Filtering SWIFT Message Format and Fields SWIFT Payment Flow SEPA Message Structure and Payment Flow MS Office (MS Excel, Word and Outlook) Proficient in e mail communication Good communication skills (Written & Verbal) Ability to support rotational shifts Ready to support on weekends How well support you

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

Knowledge and Skills Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System.

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

1. Compilation of Post Approval requirements i.e. Annual Reports, CBE-0, CBE-30, PAS, 15-Day Alert Report, PADER etc., ensuring that quality standards are met and submissions meet strict deadlines. Provident fund Office cab/shuttle Health insurance Annual bonus

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Regulatory Affairs Specialist-II Careers that Change Lives Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities and grow as we grow. A Day in the Life Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Prepare, review, file, and support premarket documents for global registrations for assigned projects. Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop Regulatory Strategies for new or modified products for assigned projects. Monitor and provide information pertaining to impact of changes in the regulatory environment. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal documents for modifications to devices, when appropriate. Participate in health agency inspections & notified body audits as necessary. Author and/or review regulatory procedures and update as necessary. Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments. Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information. Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects. Ensure compliance to regulations specific to clearance and approvals of MEIC developed product s raw material and/or prototype. Minimum Qualifications Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors 4-7 years experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements. Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude. Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure; Good at English, including reading, writing, and speaking; Good Learning attitude Nice to Haves US and global regulatory affairs knowledge and experience. Experience working with cross-functional teams. Effective verbal and written communication skills both internally and externally. Experience with solving problems and concerns. Experience with project management and adherence to time schedules. Work well under pressure in a dynamic environment. Highly organized, detail-oriented, and efficient. Team player who seeks to help and learn from colleagues seeing the department success as their own Ability to manage projects to completion within and outside of the direct department and company. Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism Proactively seeks to develop and become well-versed within the regulatory landscape. RAPS Regulatory Affairs Certification (RAC). About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let s work together to address universal healthcare needs and improve patients lives.Help us shape the future. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsYou will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Looking for the candidate with Good Communication and written skills, any degree expect B.tech/B.ELooking for the candidate with Good Communication and written skills, any degree expect B.tech/B.E Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Strong knowledge of cGMP regulations, quality management systems, and industry best practices. Exposure to international regulatory inspections like USFDA, EDQM. Exposure to international regulatory inspections like USFDA, EDQM Required Candidate profile Bachelor’s degree in pharmacy or master’s degree in chemistry from a recognized university.6-9 years of experience in quality assurance roles within the pharmaceutical or API manufacturing industry.

Role & responsibilities Lead and manage the Engineering department with a focus on Process Engineering and Utilities. Plan, design, and implement engineering systems to support sterile and non-sterile pharmaceutical manufacturing. Ensure uninterrupted operation and compliance of all utility systems including HVAC, WFI, clean steam, compressed air, chilled water, and effluent treatment. Develop and implement SOPs for engineering operations, preventive maintenance, and calibration. Ensure compliance with cGMP, GEP, and regulatory requirements for all engineering activities. Lead capital projects including facility upgrades, equipment installation, and utility expansions. Coordinate with QA, Production, and Validation teams for timely execution of qualification and validation activities. Monitor and control energy consumption and implement energy-saving initiatives. Ensure timely execution of preventive and breakdown maintenance for all equipment and utilities. Lead root cause analysis and implement CAPA for engineering-related deviations and failures. Ensure readiness for regulatory inspections and audits by maintaining documentation and compliance. Develop and manage engineering budgets, procurement plans, and vendor management. Lead the recruitment, training, and development of engineering personnel. Ensure safety practices are followed across all engineering operations. Drive continuous improvement initiatives in process efficiency, equipment reliability, and utility performance. Ensure timely review and approval of engineering documents including URS, DQ, IQ, OQ, PQ, and validation protocols. Should have Knowledge on TPM Principless Drive Asset Robustness Program with Energy Efficiency. Coordinate with external agencies for statutory compliance related to utilities and infrastructure. Ensure proper documentation and control of engineering records and drawings. Support technology transfer and scale-up activities from R&D to commercial production. Any other assignment given by higher management. Preferred candidate profile Educational qualification : B.E./Btech or M.E./M.Tech in Mechanical, Electrical, Chemical, or related engineering discipline. Minimum work experience: 15 to 20 years in pharmaceutical manufacturing with strong exposure to sterile operations and utility systems. Skills & attributes: Technical Skills Expertise in utility systems (HVAC, WFI, clean steam, etc.) and process equipment. Experience in project management, equipment qualification, and validation. Knowledge of regulatory requirements (USFDA, EU GMP, WHO, etc.). Familiarity with engineering documentation and QMS systems. Hands-on experience in energy management and automation systems. Behavioural skills Strong leadership and team management capabilities. Excellent problem-solving and decision-making skills. Effective communication and cross-functional collaboration. High attention to detail and commitment to compliance and safety.

Review DCS alarms. Ensure that batch charging and other manufacturing operations are strictly in accordance with the BMR/SOP and align with current GMP practices. Maintain manufacturing records online, ensuring compliance with data integrity practices. Collect samples of intermediate/in-process materials and send them to the IPQC/QC lab. Enter and verify production-related inputs in the SAP system. Review and ensure the generation of PISCADA reports. Transfer finished goods using the "Finished Goods Transfer Note." Monitor and ensure minimum stock levels of consumables, logbooks, and status labels. Ensure preventive maintenance of all equipment according to the schedule. Coordinate with service departments (QA, QC, Stores, E&M) for production-related activities. In case of any major abnormalities in the production area or activities, stop the activity immediately and inform superiors/production managers. Maintain housekeeping standards in the plant and ensure equipment cleanliness. Follow safety instructions/procedures and ensure the use of safety gear during work. Attend GMP and safety training sessions and implement the outcomes in the workplace. Conduct training for staff as a trainer. Be aware of the location and operation of firefighting equipment. Report any incidents or near misses in the MySafe portal. Rectify all safety and GMP-related observations. Do not leave the work area unattended or depart without prior permission from the manager. Manage the allocation of Isoflurane bulk to various customers. Participate in initiatives such as AET and CSR. Perform the duties of a senior in their absence or as authorized by a senior. Prepare and execute operational and performance qualification protocols. Prepare SOPs, BMRs, protocols, records, etc. Handle DocuSign and track related activities. Manage all QMS activities related to production.

Job Purpose: Maintain compliance to Quality Management System to deliver consistent quality medical devices to fulfil future strategy of Cipla. To Lead and establish Quality Management System for medical devices as per EU Regulatory requirements, CDSCO and ISO 13485 requirements and develop and implement documentation such as SOPs, Quality manual etc. to define the framework. Monitor effective implementation of Quality System across function and appraise Management Representative. Responsible for monitoring metrics/KPI for medical devices starting from design, manufacturing, postproduction. Compile data for management review meetings. Responsible for coordinating with cross functional team for internal / external audit compliance for ISO and CE marking Responsible for surveillance of regulatory guidance/ standards applicable to medical devices in the respective geographies in which Cipla products are distributed. Key Accountabilities: Develop, establish and maintain the QMS for medical devices according to EU MDR and ISO 13485 requirements. Surveillance of new/updated regulatory guidance/ ISO standards applicable to medical devices as per Ciplas product portfolio to ensure compliance to latest regulations. Surveillance of EU noncompliance reports / CDSCO / USFDA etc that are applicable to medical devices manufactured by Cipla to enable continuous improvement. Execution of Quality Management Review meeting for Medical devices and implementation of actions derived in the QMR meetings. Conduct audit of Vendors / contract manufacturers/ outsourced activities associated with medical device manufacturing/ servicing/ testing/ distribution. Ensure timely submission of quality documents to fulfil regulatory requirements. Major Activities / Tasks: Develop and establish Management responsibility system as per ISO 13485 and EU MDR Develop and establish design control system for EU market. Develop and establish key performance indicators (KPIs) for monitoring site performance and effectiveness of QMS as per ISO 13485. Prepare SOPs, Quality manual etc.as per ISO 13485/ EU MDR. Responsible to maintain compliance to ISO 13485 by adhering to SOPs and ensuring control and oversight over adherence by respective depts to SOPs. Periodic review of SOPs related to medical devices as per regulatory requirements and update. Arrange training and promote awareness among cross functional teams on ISO 13485 QMS and CE Marking Ensure readiness from QMS standpoint for internal and external audits. Provide guidance and support during internal and external audits examining compliance to EU MDR/ISO 13485 requirements. Co-ordinate with cross functional teams for internal/ external audit compliance. Create library of ISO standards. Review new/upcoming/ draft/ revised/ final regulatory guidance/ ISO standards related to medical devices applicable as per Ciplas product portfolio. Gap assessment of the guidance / standards in comparison to QMS at Cipla and identify suitable actions prior to implementation of the guidance/standard. Monitor implementation of the actions to enable continuous improvement. Schedule quality management review (QMR) meeting for medical devices. Collate data required for the QMR and prepare the presentation on site performance to monitor effectiveness of Quality management system. Appraise management representative regarding critical issues. Monitor implementation of the action plans derived from QMR by coordinating with other cross functional team. Audit of Vendors supplying Medical devices and Invitro diagnostic kits, completing audit documentation and verifying actions taken by the audited site to correct non-conformances observed. Audit of CMOs manufacturing medical devices, completing audit documentation, and verifying actions taken by the audited site to correct non-conformances observed. Audit of outsourced activities related to medical devices manufacturing/ servicing/ testing/ distribution. Coordinate with RA, QA team and Pharmaco vigilance team through emails and phone to enable timely submission of the documents. Major Challenges: Establishing Quality Management System for Medical devices according to EU MDR / ISO 13485 is new for Cipla, hence developing and maintaining it will be a challenge. Cross functional support is key in ensuring adherence to QMS, as challenge is awareness about EU/ ISO 13485 certification requirements is low in cross functional teams such as IPD/ RA/ SCM/FPS/ DSD, Marketing. Same can be overcome by promoting awareness about EU MDR/ISO 13485 requirements at the outset/ from time to time. Engage in Notified bodies audits for ISO and CE marking audits and coordinate with all Cipla teams for audit management. Coordinate with Cipla team for audit compliance. Skills & Knowledge: Educational qualifications: MSc./ MPharm/ if MTech then in Biomedical engineering; Certificate courses/diploma in ISO audits highly welcome Relevant experience: At least 9-10 years of experience in Quality of Medical Devices/IVDs /Implants Experience in regulated market product approvals e.g. US FDA is a high plus

To support and execute end-to-end regulatory documentation and review for site transfer projects, from data collation to submission. Key Responsibilities: Coordinate data collection from CFTs for pre submission and site transfer packages. Review all plant-related documents Prepare and submit dossiers for product registrations in Europe, US, UK, Canada, Australia, Brazil markets, ensuring adherence to country-specific guidelines and requirements. Prepare and maintain regulatory trackers. Support query responses and internal audits related to site transfers. Ensure documentation quality and compliance with ICH/FDA/EU/Health Canada guidelines. Qualifications: M. Pharm with 48 years of RA experience. Hands-on in Module 3, eCTD components, and lifecycle submissions. Familiarity with change management systems (Trackwise or similar).