683 Change Control Jobs - Page 26

Handling of Laboratory Incidents, Change Control, Deviations OOS & OOT Handling of CAPA, Coordinate with technical team for timely closure of QMS documents. Writing SOP's. Support Internal & External Audit Finding Responses.

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Receipt, storage & destruction of superseded SOPs. 9 Preparation of process validation protocol & Report. 10 Receipt & storage of executed validation protocol & Report 11 Receipt & storage of executed Qualification documents of equipment & instruments 12 Stability studies documentation with help of Quality control. 13 Preparation & Revision of SOPs of Quality Assurance department. 14 Compliance and preparation of Audit Report. 15 Maintenance of control sample room & Documentation room. 16 Training of sub ordinates & evaluation. 17 Preparation of Training schedule and its implementation and monitoring. 18 Identification of training needs to internal/ external to the sub ordinates. 19 Compliance of Audit Report from Government authorities (FDA). 20 Any other activity assigned by the management.

1) Understand the CTQ for a process 2) Ensure complaince of process parameters and product parameters for the responsible area 3) Educate the operators and ensure adherence of GMP/quality systems in the process 4) indentify non conformances, Deviations- segeregate and quarantine the materials and reporting 5) Basic quality trouble shooting guidelines implementation to assist production to ensure Quality 6) System updation in ERP/ material clearance process completion 7) Deviation process controls 8) customer CTQ CAPA implentation points checking for effectiveness 9) maintaining of the correspoding Lab equipments and testing as per audit plan and reporting and taking actions on NC 10) Reporting of abnormality on Machine quality automations like EVS, magnetic separator etc.,

Role & responsibilities QMS, CAPA, OOS, OOT, CHANGECONTROL, Preferred candidate profile B.Sc / M.Sc Chemistry With relevant experience Perks and benefits

Kaliberr bioscience pvt ltd is looking for Micro Sr . Executive to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest available data Reviewing existing financial policies and procedures to ensure regulatory compliance Providing assistance with payroll administration Keeping records and documenting financial processes

Kamla Homes is looking for Trainee Officer - Packing to join our dynamic team and embark on a rewarding career journey Assist in the packing line operations and material setup Check packaging materials and labels for accuracy Maintain cleanliness and batch documentation Learn GMP guidelines and SOP compliance

Kamla Homes is looking for Officer (QMS)- QA to join our dynamic team and embark on a rewarding career journey Implement and maintain Quality Management Systems Conduct internal audits and ensure documentation accuracy Support CAPA processes and compliance reporting Coordinate with departments for system improvements

Kaliberr bioscience pvt ltd is looking for QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Dr.Medcare is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey. Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

About Us Tata Consulting Engineers Limited (TCE) is the largest Indian private sector engineering and project consultancy and an emerging global leader in integrated engineering solutions. With more than 60 years of engineering excellence, TCE has a presence in over 64 countries and over 12000 completed projects, the company operates in 3 core Industry segments -Infrastructure (Water, Environment, Urban Development, Buildings, Manufacturing Facilities, Ports and Harbours, Transportation), Power (Thermal, Hydro, Nuclear, Renewable, Transmission and Distribution) and Resources - Hydrocarbons and Chemicals (Oil, Gas and Refineries, Chemicals, Petrochemicals, Fertilizers, Speciality Chemicals, Pulp and Paper, Cement, Food, Pharmaceuticals and Beverages, Tyre, Glass) as well as Mining and Metallurgy (Mining, Geology, Beneficiation, Steel, Non-ferrous). TCE serves domestic as well as international markets and is known for several first-of-its-kind projects offering Engineering Studies, Design Engineering Services, Project Management Consultancy Services, OPEX and IIOT across all three verticals. A part of Tata Group - India’s most respected group, TCE is a 100 percent subsidiary of Tata Sons Limited Design your Future with us At TCE, you will experience a supportive environment that empowers you to excel, whether you are based in our offices or at a client site. We embrace diversity, equity, and inclusion, fostering a workplace where every individual can thrive by contributing their unique skills and perspectives to deliver exceptional results for our clients. Our comprehensive compensation and benefits packages are designed to meet the diverse needs of our employees and their families, complemented by a robust global well-being program. As a leading global infrastructure firm, we are committed to your growth and success, offering access to cutting-edge technology and impactful projects that offer flexibility and significant professional opportunities. Join us and become part of a global company that values your potential and supports your career development. Purpose & Scope of Position The Project Engineer (PE) will be part of an engineering stream providing engineering services to large and small projects. The PE provides support to the Project Manager (PM) and Engineering Manager (EM) and is responsible for supervising a team of working engineer and designers. The PE provides leadership and assists in the resolution of all technical issues related to the discipline. Experience • 10+ years of experience in relevant design discipline • Experience in engineering and package coordination Qualification • Postgraduate or graduate in an engineering discipline • Registration as a professional engineer with the governing authority (preferable) Key Responsibilities 1. Assist the PM and EM with the delivery of project requirements as they relate to scope, quantities, cost and schedule 2. Prepare Engineering Work Packages (EWPs) in consultation with the Engineering Manager 3. Assist in the compilation and delivery of monthly engineering status reports 4. Participate in and contribute to design reviews 5. Represent the discipline in the project engineering coordination meetings 6. Prepare and/or review project procedures, standard specifications and design criteria 7. Review and evaluate technical work prepared by junior engineers, intermediate engineers, designers, technicians and technologists 8. Ensure relevant technical experts are involved in the design process as required and facilitate the sharing of technical expertise across projects 9. Perform conceptual and detailed engineering design 10. Prepare engineering work (calculations, reports, specifications, evaluations, recommendations etc.) where required 11. Provide and/or coordinate training for resources assigned to the project 12. Work to ensure the implementation of safety in design 13. Ensures measurement of progress on all contracts for reporting and progress claim purposes. 14. Responsible to ensure timely availability of discipline data to other disciplines, and work with fellow PEs and EM on integration of the same and resolution of any issues and challenges 15. Document value additions and best practices and ensure communication of the same to fellow project engineers of other projects and discipline leadership 16. Support technology team/ Project team for development and automation works as required. 17. Ensure compliance to all quality and document management processes within TCE and as agreed with customer. 18. Manage performance data of reportees and provide periodic feedback. 19. Provides resource loading forecast to TL. 20. Keeps records of learning’s during the project and provides inputs to PM during job closure report. 21. Prepare technical specifications/ bid evaluation/ technical recommendation where required 22. Interact with the discipline engineers of customer during entire life cycle of the project and beyond. Competencies Action Oriented Manages Complexity Technical Knowledge Quantity of Work Knowledge

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

NUTRIS CROP SOLUTIONS INDIA PVT.LTD is looking for CEO to join our dynamic team and embark on a rewarding career journey. Develop and implement organizational strategies. Lead and manage executive teams. Ensure organizational performance and growth. Collaborate with internal and external stakeholders. Prepare reports and documentation. Stay updated with industry trends and innovations.

Carry out solar resource assessment for various available resources based on the Project location Analysis of Energy Yield Numbers for various scenarios with different technology and optimizing the Plant Layout. Providing BOQ for the Project based on the AC & DC Cable Loss Calculation, Optimized Scenario. Evaluation of Module technology based on the documentation received from Module OEMs. Evaluation of Robotic Cleaning Solution technology based on the documentation received from Module OEMs. Plan Module Factory Visits for Inspection of the Module Manufacturing Process. Contribution to interface with Lender's Engineer and support Lenders due diligence. Working along with O&M Team to perform EL and FTR for the evaluation the health of the installed modules. Thorough understanding of ISO 2859 AQL Criteria for sample selection of modules for EL & Visual tests. Preparation of SOPs and Checklists for the methodology followed for various processes. Understanding the tests performed on modules. Understanding the test results and taking appropriate decision in selection of modules.

A. Job Objective Monitor and review In Process quality control checks to meet the required quality compliance as per specifications. Strategic and planning Functional Core:- Review and provide decision based on the IQC sheet Online feedback to production for correction Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same. Monitoring CAPA during shifts. Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same. Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR. Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System Ensuring document verification generated during shift on daily basis against defined standards Internal process Preparation of various reports Maintenance and verification of gauges to ensure proper calibration of these equipments on a regular basis in each shift Ensure verification of shade against master and Macbeth report Verification of daily profiles and online graphs Periodically conduct process, product and systems Audit. To provide data for annual product quality review & Participate in APQR and finalise the recommender's People development Ensure proper manning and shift handling, shift activities. Effective training to the operators with evaluation for compliance. Effective manning to utilization of available sources.

To follow safety rules in the premises according to the company norms. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. Responsible for operation Maintenance and cleaning of External washing and Vial washing & Depyrogenation tunnel areas. Operation and cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Decartoning activity. Responsible for monthly frequency activity. Responsible for line clearance before start of the Activity. Preparation and periodic revision of SOPs related to respective area. Monitoring of DP, RH and temperature area in their respective area. To maintain the BMRs and other log books in respective area as per cGMP and SOP. Responsible for timely completion of calibrations and validations in coordination with Eng. and QA related to respective areas. Responsible for the Operation and cleaning of Automatic visual inspection. Responsible to perform visual inspection of the products /media filled vials as per the sop. Operation and cleaning lux mater, visual inspection table. Operation and cleaning of glove integrity and filter integrity testers Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area. Responsible for cleaning and storage of all the filling machine accessories and change parts Operation and cleaning of table mounted LAF and Ceiling mounted LAF Operation and cleaning of steam sterilizer and HPHV steam sterilizer. Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern. Responsible for ensuring garments washing, drying and folding activities Timely completion of SOPs Training and On the job trainings related to respective area. Responsible for Maintenance of cleaning in in External washing and vial washing area & Depyrogenation tunnel areas and f Component preparation and sterilization area. Cleaning and sanitization of drain points in External washing and Vial washing & Depyrogenation tunnel areas and f Component preparation and sterilization area Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

Develop & update SOPs, ensure compliance, prepare MSDS/specs, review BMRs, check COAs/labels, maintain documentation, conduct training, perform audits, and support corrective actions to uphold quality standards across operations.

Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Responsibilities: * Ensure compliance with regulatory requirements through quality control measures * Conduct process validations, cleaning verifications & change controls * Prepare validation protocols & reports

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

API -QA

Roles and Responsibilities: Work experience of Accounts Payable/Procure to Pay Knowledge on GST, IGST, CGST, TDS, VAT Invoice Processing/Invoice audit/vendor payments experience must SAP end user experience in FI Module for Financial accounting is must. Advanced Excel, PPT, MIS report and other analytical reporting knowledge & experience is an added advantage. Knowledge about different kind of payment methods and payment term. PO and non PO invoices handling Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

India Quality Manager India HOW MIGHT YOU DEFY IMAGINATION Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has also invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an India Quality Manager in India . Live What you will do Reporting to the Senior Manager International Quality JAPAC, the responsibilities of your role will cover, but are not limited to the following: Main Responsibilities Implement Amgen Quality Management System Identify Continuous Improvement opportunity for Quality Management System Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations Act as Quality-related interface with internal and external customers (i.e. Change control, Non Conformance, Product Complaint, Product Recall, Audit/ Inspection) Support local testing Support BD project and product launches Liaise with internal and external partners to manage day to day operations associated with distribution operations Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events Develop and Maintain the Quality Agreements with local distributors and partners Develop reports and provide the necessary communications throughout the organizations Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors/stockist on-boarding training Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India. Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion Interact with local regulators as needed. Keep the Senior Manager International Quality – JAPAC informed of the progress of projects and goals and advise on the potential areas of risk/ concern and new developments that may impact the company Support Named Patient Program Supplier ManagementPerform quality oversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers , contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc. Apply advanced knowledge of Indian and global market regulations to assess supply security risks. Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit/audit and (if needed) Person in Plant placement, etc.. Support in identifying, assessing and addressing supplier’s GMP/GDP risks in collaboration with Amgen sites. Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals. Provide support for regulatory inspections of key facilities as needed. Win What we expect of you Qualifications Pharmacist Registration in India. Hold a valid practicing certificate as Pharmacist in India. In-depth knowledge and experience of Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP). Experience with Quality Management Systems including but not limited to change control, deviation, validation, complaints, disposition and audits/inspections. Experience with Commercial Quality Operations and third-party management. Experience with distribution models and/or establishment of new entity procedures a plus Thrive What you can expect of us As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being. Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Profile Manager Job description : Role Description A service delivery manager is responsible for making sure that services are being seamlessly delivered to the clients of an organization. They are in charge of a variety of tasks, such as leading project teams, rectifying reliability issues, monitoring progress, tracking KPIs, and managing budgets. Role & responsibilities : - Single Point of Contact SPOC for Technology with respect to Operations. - Primarily client/user facing - Building a personal relationship with both internal & external clients - Support business operations to meet Technology SLA across centres/clients handled. - Monitoring overall performance of services - Track and Maintain Client SLA (Internal & External) - Building service reports - Identifying the reporting requirements - Ensure timeliness and accuracy of SLA, uptime and call Analysis reports - Service reporting and sponsoring service review meetings (Daily, weekly and monthly SLA review with the clients) - Managing customer expectations Weekly/monthly conference calls with on all areas of technology support functions. - Would be responsible for technology and systems availability, technical SLA management with internal/external clients, Developing of IT service continuity plans with SMEs - Review SLA report on a daily basis, carryout call analysis and feed the results back to technology for proactive actions. - Work with Incident Management team and respective other departments for faster restoration of services - Good communication around issues and opportunities get things done, make things happen - Manage Customer VOC w.r.t Technology - Manage all change controls, ramp ups, and escalated complaints (only high business impacting). Involve service support, solution design and project management teams if needed. - Ensure all established processes are being practiced for operations interfacing with technology and support desk. - Building Service improvement plans - Work with Support managers to build capacity plans - Understand the client technology solution and find areas of improvements - Removing all obstacles to customer satisfaction and / or financial performance - Working in a typical ITIL/ISO20000 frame work - Vendor/3rd party management responsibilities - Communicating across organizational boundaries from engineers through to senior managers - Looking out for clients and FSLs long-term interests - Collaborating with senior management on client account management and growth Apply Save Save Pro Insights Location - Bhopal,MP,Kerala,Cochin,Kochi,Trivandrum,Thiruvananthapuram,Bengaluru

Role & responsibilities 1. Candidate must have a minimum of 7-year experience in Pharma/FMCG/Packing industries for packing materials testing. 2. Responsible to ensure compliance for the all the PM supplied at CML by the multiple vendors. 3. Well known for QMS (change control/deviation/incident/handling of OOS). 4. Must be aware and have expertise knowledge on all range of technologies followed for Primary, Secondary and tertiary manufacturing. 5. Able to perform packing materials testing like bottle/tube/carton/label/ shipper and other material required for pharma/cosmetics and Animal health products. 6. Able to review escalation made by CML related to PMs and lead Investigation with technically soundful investigation reports. 7. To conduct audits at CML and Vendor level to ensure compliance 8. Able to troubleshoot packing materials issue observed in day-to-day analysis. 9. Take PM issue related internal stakeholders and ensure closure to avoid future rejections 10. Able to do Periodic Quality Updates on PM quality/ Issues and follow up for CAPAs on internal and external failures and Audit observations. 11. Follow ups for CAPA on PM issue with Vendors through procurement and review its effectiveness. Preferred candidate profile

Role & responsibilities 1. To ensure GMP compliance on shop floor. 2. To follow SOPS and policies and perform tasks as per the SOP. 3. To perform investigation along with CFT to identify the root cause. 4. To participate in the preparation and review of investigation report for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. 5. To initiate change controls, planned deviations and unplanned deviations related to production department. 6. To provide the awareness training and SOP related trainings to concern personnel. 7. To develop skills in subordinates by motivation and on the job training. 8. To coordinate with internal and external auditor along with CFT. 9. Drafting of investigation for OOS, OOT, product quality complaints and unplanned deviations related to manufacturing. To prepare review and timely compliance of audit related observations of production department . Preferred candidate profile B.Pharma / M.Pharma candidate having regulatory exposure of handling QMS systems in pharma industry and sound knowledge technical knowledge as well as good communication skills. candidate must possess 5 to 10 yrs experience in handling QMS process and must have worked in the past in Quality/Manufacturing function.