181 Oos Jobs - Page 3

Strong 1-4 years of knowledge and Experience in Analytical QA

Role & responsibilities Incharge for QMS activities, Preferred candidate profile Should have good knoledge about QMS, Validation, calibration , qualification, re-qualification, change control. CAPA, OOS, OOT & Investigation. Mainly for all Process equipments and Utility ( HVAC System, Purified System, Refrigerator System, Air Compressor System & Boiler ) Exposure with Regulatory Aduits.

Roles and Responsibilities Role Overview Lead the Quality Control (QC) laboratory operations Ensure compliance with cGMP , GLP , and regulatory standards (e.g., WHO, FDA) Supervise testing of raw materials, in-process samples, and finished products Oversee stability studies , method validation , and instrument calibration Managing team and work allocation Key Responsibilities Review and approve analytical reports , COAs , and SOPs Investigate OOS/OOT results and implement CAPA Coordinate with QA, Production, and Regulatory Affairs for product release Maintain audit readiness and data integrity

Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.

You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Reviewing and approving all documents including SOPs, Spec & STPs, Forms, protocols, and reports will be crucial to ensure compliance. You will also review annual product quality review reports and provide training on cGMP topics to employees at the site. Additionally, you will support customer audits/visits and regulatory audits, as well as provide necessary documentation for amendments, annual updates, regulatory filings, and CMC supporting documentation. Your role will also involve filling out questionnaires, declarations, and quality agreements. Finally, you will execute any additional responsibilities assigned by the Head of Department.,

Filling & review BMRs, MFRs, SOPs, ECR Maintain records for CC, CCF Ensure documentation aligns with GMP Requirement Support audits & investigations with accurate records. Coordinate with production & QA for data verification. Required Candidate profile Must Require Knowledge for filling & Review of BMR BMR, CC, CCF, and OOS handling Documentation practices & regulatory understanding Good communication & MS Office proficiency

COMPUTER OPERTOR WITH FULLY KNOWLEDGE OF TALLY MAKING ENQUIRY , QUOTATION, INVOICE Operate and monitor computer systems and equipment. Perform routine maintenance and troubleshooting of computer hardware and software. Ensure the security and integrity of data and systems. Collaborate with IT staff to resolve technical issues. Maintain accurate records of computer operations and activities. Provide technical support and assistance to users. Stay updated with the latest advancements in computer technology.

Long Description 1 Exposure of execution of planning of Inprocess, Finished product, stability and cleaning validation samples of MDI / DPI formulation. 2 Exposure of compliance to all cGMP, GxP or any other regulatory requirements, including EHS requirements. 3 Maintenance of GLP in the Laboratory. 4 Having knowledge of Analytical Instruments like HPLC, GC, GCMS, LCMS, UV, IR, KF, ACI, NGI, DUSA, Spray Pattern etc. 5 Exposure of Laboratory investigation like OOS, OOT, Incidence, Deviation, CAPA, Change control etc. 6 Exposure of Stability sample management & Regulatory Audits. 7 Exposure of Analytical method transfer, Analytical method validation / Verification activity. 8 Exposure of Calibration of Analytical Instruments & Equipment’s 9 Compliance to observation noted during internal and external audits. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Graduation in Pharmacy Work Experience 10 to 15 years.

Key Responsibilities Process Improvement & Automation Identify repetitive and manual processes ripe for automation across reporting, documentation, and administrative workflows Lead initiatives to streamline operational tasks and improve capacity management Collaborate with cross-functional teams to implement scalable efficiency solutions Reporting & Analytics Own monthly reporting cycles, including dashboards, benchmarking, and methodology-based tracking Proactively refine reporting methods for better transparency and time savings Document & Site Management Maintain and manage SharePoint and Sphere sites, including user permissions, file structures, and content consistency Support migration planning and execution from legacy platforms (Box) to MyDocs (DocShare) Policy Alignment Cycles (PAC) Coordinate PAC verification and documentation efforts twice annually, ensuring change-tracking and comment logging are consistent Business Impact Assessment (BIA) Support Verify and update application lists and organizational structures by location Ensure data integrity and audit-readiness of structured documentation Required Skills & Qualifications Strong eye for identifying automation opportunities and driving operational efficiency Highly organized, detail-oriented, and independently driven Familiarity with platforms like SharePoint, DocShare, Sphere, and other enterprise documentation tools Competence in reporting tools and dashboard creation (Excel, Power BI preferred) Excellent communication and collaboration skills

Key Responsibilities: Administer and maintain SQL Server databases, ensuring high availability (HA) and optimizing performance. Perform regular database backups, monitoring, and auditing to maintain data integrity and security. Utilize PowerShell scripting to automate routine database tasks, streamline processes, and improve operational efficiency. Perform performance tuning to optimize database systems for improved speed and responsiveness. Monitor and troubleshoot database-related issues, ensuring quick resolution of any operational problems. Implement and maintain disaster recovery procedures to ensure data availability and minimal downtime. Collaborate with other IT teams to ensure databases support application development and deployment. Required Skills: SQL Server Administration (3 to 5 years): Experience in managing SQL Server databases, including high availability (HA), performance tuning, backups, monitoring, and auditing. PowerShell Scripting: Proficiency in using PowerShell to automate tasks and enhance database management processes. Strong troubleshooting and problem-solving skills related to database systems.

Job Summary We are seeking an associate for the Quality Control team responsible for conducting investigations in case of any failure, incidents, market complaint, OOS & OOT. The role involves ensuring accuracy in investigation, technical report writing/documentation, adherence to safety procedures and reporting discrepancies. Roles & Responsibilities • You will be responsible for conducting investigations in case of any failure, incidents, market complaint, OOS & OOT. The role involves ensuring accuracy in investigation, technical report writing/documentation, adherence to safety procedures and reporting discrepancies. • You will ensure accuracy of the documentation before submitting it for the Group Leader’s review or uploading online. • You will adhere to safety precautions and procedures during analysis. • Lab safety, following JSA (Job Safety Analysis), and using proper PPE (Personal Protection Equipment) at the workplace are emphasized. Qualification Educational qualification: A Bachelor’s degree in Chemistry, Analytical Chemistry, or a related field Minimum work experience : 5 to 7 years of experience in a laboratory setting, preferably in the pharmaceutical or related industry Skills & attributes: Technical Skills • Proficient in various analytical techniques, including sampling and analysis of packaging and raw material samples. • Experience with the operation and maintenance of analytical instruments, ensuring proper use and care as per SOPs. • Competent in SAP activities related to sample tracking, documentation, and data entry. • Knowledgeable about cGMP, SOPs, and STPs, ensuring accurate documentation and adherence to specifications. • Adheres to safety precautions and procedures during analysis, emphasizing the importance of lab safety, JSA (Job Safety Analysis), and proper use of PPE (Personal Protective Equipment). • Expertise in handling and upkeep of the chemical and solvent store, including the preparation and maintenance of volumetric solutions and reagents. Behavioural Skills • Keen attention to detail in analysis and documentation, ensuring accuracy in all tasks. • Effective communication and collaboration skills for communicating with the Group Leader, reporting discrepancies, incidents, and providing timely updates. • Takes initiative in ensuring the proper use and care of instruments, timely destruction of samples, and other assigned responsibilities. • Demonstrates problem-solving skills in addressing discrepancies, incidents, and ensuring smooth laboratory operations. • Upholds ethical standards, compliance with SOPs, and follows regulatory requirements in all activities. 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/#!/

Key Responsibilities: Administer and maintain SQL Server databases, ensuring high availability (HA) and optimizing performance. Perform regular database backups, monitoring, and auditing to maintain data integrity and security. Utilize PowerShell scripting to automate routine database tasks, streamline processes, and improve operational efficiency. Perform performance tuning to optimize database systems for improved speed and responsiveness. Monitor and troubleshoot database-related issues, ensuring quick resolution of any operational problems. Implement and maintain disaster recovery procedures to ensure data availability and minimal downtime. Collaborate with other IT teams to ensure databases support application development and deployment. Required Skills: SQL Server Administration (3 to 5 years): Experience in managing SQL Server databases, including high availability (HA), performance tuning, backups, monitoring, and auditing. PowerShell Scripting: Proficiency in using PowerShell to automate tasks and enhance database management processes. Strong troubleshooting and problem-solving skills related to database systems.

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Work Experience 12 to 15 years of experience in Pharma Vendor Audit Management 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3. To execute vendor Audits, CAPA tracking, and qualification documentation 4. To schedule and monitor the Vendor Audits 5. To work on VQ special projects in coordination with Project IT team 6. To track the project till its implementation and Go Live across all sites Technical , behavioral & managerial 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 5. Result Orientation 3. Customer Centricity Education Masters in Pharmacy Post Graduation in Science or Chemistry

Responsibilities: * Develop analytical methods using HPLC, ELISA , colorimetry & spectrophotometry. * Validate methods according to GLP & GDP guidelines. * Conduct quality control testing on biologics products.

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for production activities by coordinating with PPIC, PDL, Engineering, validation and QA. Work Experience 8 to 10 Years Education Graduation in Pharmacy Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management

Responsible for maintaining GLP and GDP in QC department. Review of SOPs, Specifications and STPs. Identifying training needs of the staff in the QC department. Ensuring that all Analytical Instruments are in good working condition Ensure and maintain AMC / Calibration / Qualification schedule and status of QC Instruments / Standard Weight and other measuring instrument and timely completion of the same as per the schedule. Up keeping the laboratory all the time ready for regulatory and customer audits. Responsible for QC QMS Activity i.e Lab Incident, Deviation, OOS, OOC, CAPA for their timely initiation, investigation and closer. Compliance for maintaining Working Standard and Reference Standard in the lab. Ensure and verification of Log Books / Analytical Documents and online documentation in the lab. Compliance for Columns / Chemical / Volumetric Solution / Reagent Solution management Compliance for Instrument Tags / Labels/ QC Status Board / NABL analysis Responsible for maintaining and continuous improvement as per ICH Q7 A and relevant regulatory guidelines. Ensuring a safe environment is maintained in the laboratory. Regularly provide the training to the QC Colleagues on SOP, GMP and GLP. Ensure the Analytical Method validations as well method transfers are conducted with an approved protocol and duly documented and approved. Present GLP and GMP related activities in the weekly review meeting and monthly review meeting to the Senior management. Regularly supporting and providing the data as per the requirement from customer and regulatory. Develop & prepare work procedures to minimize OHS risks and Adverse Environmental Impact. Involve the regulatory and customer audits to provide the answers for queries Ensure the data integrity checks are conducted regularly to evaluate the health of the Quality system and implement actions as required. Control and issuance of loose formats and hard books. Preparation and review of Standard Operation Procedures, Specification, Test method and Quality control procedures. Responsible for review and release of batches-QC analytical Documents. Responsible for approval and release of products for Dispatch. As and when additional responsibilities arise, same shall be taken based on the requirement. Qualifications BSC / MSC / B Pharmacy / M Pharmacy

Please share your CV on sneha.shinde@embio.co.in or kchoudhary@embio.co.in for further process.

NAB is looking for Analyst to join our dynamic team and embark on a rewarding career journeyGather, analyze, and interpret complex datasets to identify trends, patterns, and insights that support strategic decision-making within the organization.Develop, maintain, and update detailed reports, dashboards, and visualizations to communicate key metrics and findings to stakeholders.Collaborate with cross-functional teams to understand business needs, translating them into data requirements and actionable insights.Conduct market research, competitor analysis, and customer behavior studies to inform business strategies and improve performance.Monitor data integrity and accuracy, implementing quality control measures to ensure reliable, consistent reporting.

Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion of training. 7. Review of Master formula and technology transfer documents for API sites. 8. Master product label information update in Traces application as per the site requirement. 9. To provide training of SOPs, cGMP, or other modules as per the requirement. 10. Review of SOPs related to various departments of corporate functions (e.g. CPRL, PAN Lab, HR etc). 11. Scheduling and participation in self-audits (Sites and corporate functions). 12. Regulatory and customer audit support to sites. 13. Review of Specifications for raw material, intermediate, finished API, working standard, GTPs of API Sites in DocuSign. Master and making effective through DocuSign and distribution of controlled copies to site and CFTs. 14. Handling Customer Questionnaires, Regulatory Agencies Questionnaires and Customer queries as per the requirement. 15. Participation in Quality related meetings. 16. Shall perform any other related work/projects assigned by CQA HOD/Section head.

Job Summary We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards. " Roles & Responsibilities You will be responsible for executing or assigning in-process activities during shifts, conducting line clearances, material verification, overseeing start-up of machines, and coordinating sampling activities to ensure product quality and compliance. You will be responsible for executing or assigning the execution of batch records and log books, filling in various applicable formats, including line clearance and sampling formats, along with batch records review sheets. Your tasks also involve reviewing the records maintained by the Production team, creating additional records as needed, conducting all documentation with respect to Quality Assurance (QA) activities, ensuring that documentation is happening online, and follow the incident reporting system in the case of deviations. You will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team. You will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor. Your responsibilities also include verifying whether the manufacturing facility meets basic Good Manufacturing Practice (GMP) requirements at all times, including facility upkeep, environmental conditions, segregation of materials, and status labeling. In case of deviations, you will follow the incident management process. You will provide essential support to the supervisor in conducting investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT) results, incidents, etc. by collating data and conducting interviews. You will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time. You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records. You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed. " Qualification Educational Qualification A B.Pharm. or Post-Graduation (Life Sciences) Minimum Work Experience 4 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development Skills & Attributes Technical Skills: A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization. In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs. Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities. Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market. Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements. Ability to understand and implement organizational policies and ensuring compliance. Behavioural Skills: Demonstrates a commitment to continuous learning. Strong communicating and influencing skills. Displays analytical and logical thinking abilities. Is self-motivated and takes initiative. Adaptability to the work environment, along with being a team player. Ability to go beyond boundaries, showcasing a proactive and innovative approach. " Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon... " Benefits Offered At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards... " 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... For more details, please visit our career website at https://careers.drreddys.com/#!/ "

Job Summary We are looking for an individual for the SIT Team to oversee the investigation of major and critical deviations, working closely with Cross-Functional Team (CFT) members to identify root causes and implement corrective and preventive actions. The role involves active participation in investigating Out of Specification (OOS) cases, ensuring accurate classification in the DCMS deviations log, and providing support during regulatory inspections. Roles & Responsibilities • You will be responsible for overseeing the investigation of major and critical deviations from the outset, collaborating closely with Cross-Functional Team (CFT) members to identify root causes, corrective actions (CA), preventive actions (PA), and preparing comprehensive reports. Your will also be working on the trending of the deviations and identification of adequate action items for reduction of the same. • Your role involves active participation in investigating OOS (Out of Specification) and other relevant cases, working closely with CFT members to determine root causes, CA, PA, and report writing. • You will review minor and critical , providing constructive feedback for improvement. • Your responsibilities include periodically assessing the trending of minor deviations, highlighting or escalating key observations, regularly reviewing the deviations log to ensure accurate classification, and utilizing the Rubrics template for crafting investigation reports. • You will offer necessary support to the site in readiness for or during regulatory inspections related to investigations. Qualification Educational qualification: A Bachelor's or Master's degree in a relevant scientific field, such as Chemistry, Biochemistry, Pharmacy, or related discipline Minimum work experience : 7 to 10 years of experience in a pharmaceutical or related industry with a focus on investigations and quality assurance Skills & attributes: Technical Skills • In-depth knowledge and experience in overseeing investigations, and familiarity with root cause analysis, corrective actions (CA), and preventive actions (PA). • Expertise in investigating valid OOS and other relevant cases. • Familiarity with reviewing deviations / OOS log and ability to perform classification of data. • Ability to craft comprehensive investigation reports. • Experience in providing necessary support for regulatory inspections related to investigations. • Knowledge of regulatory requirements pertaining to deviations investigations. Behavioural Skills • Ability to collaborate closely with CFT members. • Analytical mind set for identifying root causes and developing effective solutions. • Strong problem-solving skills and attention to detail in reviewing deviations, reports, and trending data and implementing corrective actions. • Effective communication skills for report writing and escalation of key observations. • Commitment to ensuring compliance with regulatory requirements in investigations. • Ability to offer necessary support to the site in readiness for or during regulatory inspections. Additional Information looking someone with strong QC Microbiological investigation background. Should have exp in Microbiological compliance. Education :M.Sc. Microbiology Exp : 8-10 Years Industry : Injectable preferred/ OSD will be second preference Person will be responsible to manage 3 sites Microbiological compliance at Baddi

Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund

Job Description Conduct all tasks/ activities as per the applicable SOPs. Report any difficulty or deviation in the procedures/instructions to immediate Supervisor/Managers. Report any quality concerns or suggestions for improvements to Supervisor/ Managers.Preparation and Review of Quality Assurance SOP’s. Review of other departments SOP’s. Review of Master Documents such as BMR/BPR, Test batch monitoring protocols / process validation protocol and reports etc. Initiation and log in of Quality System document such as Deviation, Change Control, OOS, OOT, market complaint, Annual product review and Non conformities. Work Experience 3-5 Years Education Graduation in Pharmacy Competencies