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12 - 15 years
10 - 12 Lacs
Baddi
Work from Office
Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.
Posted 2 months ago
2 - 3 years
3 - 7 Lacs
Kozhikode
Work from Office
Crietorgroup 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.
Posted 2 months ago
2 - 4 years
4 - 6 Lacs
Kanakapura
Work from Office
Hands on experience IPQA activities for OSD (Tablets & Capsules) Experience in qualification activities for all equipments, instruments, utility and facility. Experience in handling of QMS activities, Change control managements, OOS/OOT/Deviation/incidents & Market complaint investigations. Experience in preparation & review of SOPs/Protocol/Reports etc., Experts in Line clearance, Audit trail checks, BMR & BPR Review. Experience in Analytical data review/Audit trail review, analytical QA functional activities. Hands on experience handling of self-inspection, regulatory inspection & customer audits. Experience in handling of Trainings activities and training co-ordination. Experience handling of vendor management, Supplier & service provider qualification. Experience in document management & control.
Posted 2 months ago
4 - 8 years
7 - 8 Lacs
Kanakapura
Work from Office
Hands on experience IPQA activities for OSD (Tablets & Capsules) Experience in qualification activitie s for all equipments, instruments, utility and facility. Experience in handling of QMS activities, Change control management, OOS/OOT/Deviation/incidents & Market complaint investigations. Experience in preparation & review of MFR/ SOPs/Protocol/Reports etc., Experts in Line clearance, Audi t trail checks, BMR & BPR Review. Experience in Analytical data review /Audit trail review, analytical QA functional activities. Hands on experience handling of self-inspection , regulatory inspection & customer audits . Experience in handling of Trainings activities and training co-ordination. Experience handling of vendor management, Supplier & service provider qualification. Experience in document management & control.
Posted 2 months ago
2 - 7 years
3 - 7 Lacs
Tirupati
Work from Office
Role & responsibilities Audit Trail Review Batch Release Method Validation & Transfer Review Calibration Records Review Analytical Raw Data Issuance OOS, Lab Deviation CAPA QC Review Experience in handling audits Preferred candidate profile Should have participated in Audits and exposure towards it Should be qualified in Chemistry knowledge in process and production Smart enough to understand the regulatory requirements Knowledge in regulatory and GMP. Perks and benefits As per Company norms
Posted 2 months ago
1 - 6 years
3 - 8 Lacs
Bengaluru, Visakhapatnam, Hyderabad
Work from Office
*IPQA, Line Clearence, Blending, Sampling, BMR, BPR, Calibration, Weighing Balance, In process, cGMP
Posted 2 months ago
1 - 5 years
4 - 8 Lacs
Baddi
Work from Office
Minimum 1 Years Experience in solid dosage form- Tablets. Person shall be well versed with manufacturing and packaging operations, Compression Machines, Isolators, Blenders, Bulk packing lines, Investigation , QRM Process Validation. Person with Experience in Hormone Facility shall be preferred. Followings will be the responsibilities of the position holder: Ensure compliance to cGMP Regulations, established SOPs, FO/MI and PO/PI and for all operational activities, area and equipment. Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell. Calibration maintaining documentation of In-process Quality Assurance (IPQA) instruments. Data back-up activities of IPQA instruments as per defined SOP frequency. Monitor the environmental conditions mentioned in the batch production record and SOP. Certification of batch production records for compliance and stage-wise compliance. Reporting any GMP related discrepancies, non-conformances and deviations to superiors immediately. Collection and entry of data for APR preparation. Line Clearance: Ensure physically that the area and equipment to be used for manufacturing and packaging of next product/batch are free from any material/remnants of previous product. Ensure to prevent mix up and cross contamination. Check for proper environmental conditions with respect to temperature, Relative humidity, differential pressure etc. Ensure that the Batch Production record is completed up to the previous stage. Verify the material with respect to the container labels and quantity from the batch production record. In-Process Checks: Ensure the calibration of instruments for in-process checks. In-process checks as per the approved manufacturing and packaging instructions. Enclose all the printouts generated during in-process checks along with the batch production record. All printouts shall be duly signed after checking. Inform the production manager, supervisor and quality assurance manager about the in-process failure observed during in-process checks. To record all the observations in the Batch Production Record Inspection: Inspection of the Tablets/Capsules as per SOP. Inspection of the Finished Goods as per SOP and clearance of Transfer Ticket by ensuring the quantity and batch details. Sampling: Ensure for usage of appropriate sampling tool for sampling. Ensure sampling device cleaning prior to the sampling. Sampling procedure to be followed as per SOP No. SOP019995 (Sampling of intermediates, finished product and stability samples) SOP020059 (Collection and shipment of Analytical samples of EU market). Ensure sampling of in-process finished product, process validation, cleaning validation, control samples, EU Lab testing samples stability samples, Reference Retention sample as per SOP.
Posted 2 months ago
1 - 2 years
4 - 5 Lacs
Gangtok
Work from Office
1.To Initiation , review and conduct Calibration of IPQA Instruments. 2.To review all usage logs of Manufacturing and Packing Area. 3.To review and follow up for Annual Maintenance Activity of IPQA Instruments. 4.To fill and review IPQA instruments log books. 5.To review and provide Line Clearance for Manufacturing Equipments / Packing Equipments. 6.To review Batch Manufacturing Records / Batch Packing records. 7.To participate Training programs of various cross linked SOPs and effectively ensure its implementation.
Posted 2 months ago
3 - 8 years
3 - 8 Lacs
Hyderabad
Work from Office
Greetings from Natco Pharma Limited We are conducting Walk-in interviews for the following requirements for our formulation division in Kothur. Job Requirements Department: QA (IPQA / AQA / Qualifications / Micro QA / Documentation) - 1 to 10 Years Positions: Sr Executive / Executive / Officer / Assistant Officer Qualification: M. Sc / B. Pharmacy / M. Pharmacy Hands-on experience in IPQA activities for OSD / Sterile operations. Experience in Qualification activities for all Equipments, Utilities, Instruments, and Facilities. Experience in Analytical QA & Micro QA and handling OOS, OOT, incidents, Investigations, and GLP activities. Department: Microbiology (OSD / Injectables) - 3 to 12 Years Positions: Assistant Manager / Sr Executive / Executive / Officer / Assistant Officer Qualification: M. Sc (Microbiology) Experience in QMS & GLP activities and Analytical Doc review Experience in Media Preparation and Method Validations of MLT & BET Experience in Vitek-2 Operation/Culture handling/Water Sampling / Analysis Experience in Environmental monitoring activities. Preferably Male candidates Department: Engineering (QMS / Process / Electrical) - 4 to 10 Years Positions: Executive / Officer / Assistant Officer / Sr Assistant / Assistant / Trainee Qualification: Diploma / B. Tech Hands-on experience in QMS, Documents & OQ protocol execution. Experience in Process maintenance and vendor follow-up activities. Experience in OSD Process / Packing Maintenance and Qualifications. Experience in Electrical Maintenance & Electrical substation. Should have knowledge about AutoCAD Department: Warehouse (OSD / Sterile) - 0 to 6 Years Positions: Assistant Officer / Sr Assistant / Assistant / Trainee Qualification: B. Com / B. Sc Handling of Raw / Packing Materials Knowledge of SAP & Isolator handling Experience in Dispensing & Material Management
Posted 2 months ago
2 - 7 years
2 - 7 Lacs
Ankleshwar, Jhagadia
Work from Office
JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 17) To be controlled all master documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products. 20) Preparation of documents for Certification & product registrations work i.e. FDA, Halal, Kosher, Reach. etc. Review specification, test procedure and SOP's for their deficiencies according to audit points 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per senior’s guidance. 5) To be prepare cleaning validation protocol and report as per senior’s guidance. 6) To be conduct training and evaluation done as per Schedule. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 13) To be prepared data for monthly report as per QMS and submit to senior. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products.
Posted 2 months ago
3 - 8 years
3 - 8 Lacs
Ahmedabad
Work from Office
"Hiring Event Announcement" We are organizing a Hiring Event in Hyderabad on April 6th, 2025, for our Quality, Production and operation team of Baxter Injectable Manufacturing, Ahmedabad site. Register now for open positions mentioned below. The registration window opens until 4th April 2025. Engineering, Utility (BE/B.Tech or Diploma Electrical): 4 to 8 years experience in Injectable manufacturing plant with Utility maintenance-electrical site plant maintenance activity Engineering, Technical (BE/B.Tech or Diploma Mechanical): 4 to 8 years experience in an Injectable manufacturing plant with plant machine maintenance, preventive maintenance and breakdown maintenance activity Engineering, Instrumentation/Lab maintenance (BE/B.Tech or Diploma Instrumentation): 4 to 8 years experience in Injectable manufacturing plant with Lab maintenance, calibration, validation, Instrumentation, etc,. activity QA Batch Release (M.Pharm/M.Sc/B.Pharm /B.Sc) : 4 to 8 years experience in QA batch release, Batch record review, release document preparation, release-related compliance and cross-functional team coordination for release activity QA QMS (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 8 years experience in QA QMS team with handling of QMS element, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity QA Doc Cell (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA doc control, Batch record review, document-SOP-log book issuance and retrieval, IRA & annual product review report update, etc,. QA Validation (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA validation, thermal validation, Plant machine qualification, utility, process validation, cleaning validation, and facility qualification, QMS, etc,. QA IPQA (M.Pharm/M.Sc/B.Pharm /B.Sc) : 3 to 7 years experience in QA IPQA, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. QA IPQAshiftingn chargee (M.Pharm/M.Sc/B.Pharm /B.Sc) : 8 to12 years experience in QA IPQA, shift management, manpower management, QMS, line clearance, sampling, Batch record review, in-process quality check, QMS, batch release, etc,. Micro lab QMS (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 years experience of micro LAB investigation – OOS, OOT, handling Deviation and CAPA, support in Audit response, SOP preparation, Etc., Micro lab reviewer (M.Sc/B.Sc – Microbiology/Biotechnology) : 7 to 12 Experience in analysis and review of Microbial analysis (BET, MLT, Sterility., etc), Validation of Microbiological analysis (Method validation), good knowledge of LIMS or similar software, prefer the experience of writing lab Investigation MFG QMS (Investigation)(M.Pharm/M.Sc/B.Pharm /B.Sc): 6 to 12 Experience in QA QMS team with expertise in handling of investigation, shop floor compliance, QMS elements, CAPA, deviation, investigation, audit compliance, risk assessment, etc., activity MFG Production (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable production, mixing(batch manufacturing), filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing (M.Pharm/M.Sc/B.Pharm /B.Sc): 3 to 8 Experience in Injectable packing activity. automatic visual inspection machine operation, kit preparation, VIT operator training & qualification, batch record review, etc., activity Date & Time : 6th April 2025 || 09 AM to 2 PM IST Venue : Radisson Hyderabad Hitec City, Hyderabad Registration Link copy : https://talentcommunity.baxter.com/flows/india-ptqmwtvye EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.
Posted 2 months ago
2 - 5 years
2 - 3 Lacs
Chennai
Work from Office
Responsibilities: * Conduct quality inspections on solar panels during manufacturing process * Perform pre-dispatch & pre-shipment inspections at factory & site * Ensure compliance with IPQA standards through QA/QC procedures Food allowance Health insurance Annual bonus Performance bonus Sales incentives
Posted 2 months ago
15 - 18 years
15 - 17 Lacs
Navsari
Work from Office
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.
Posted 2 months ago
3 - 8 years
4 - 8 Lacs
Ooty
Work from Office
Responsible for QA / IPQA Required Candidate profile Graduate / Post Graduate in life science with 4+ yrs experience in injectable Manufacturing
Posted 2 months ago
0 - 2 years
0 - 2 Lacs
Faridabad
Work from Office
In-Process Monitoring, Documentation, Quality Inspections, Non-Conformance Handling, Compliance, Collaboration, BMR, BPR, Compliance, Collaboration, Basic understanding of quality assurance processes, Knowledge of GMP and ISO standards 9313198637
Posted 2 months ago
1 - 2 years
9 - 12 Lacs
Bengaluru
Work from Office
Position Purpose Our Internships allow us to give a very small but select group of bright students an intensive, hands-on 2-3 months introduction to what happens in the Clearing and Post-Trade Division of a financial exchange. We are looking for highly motivated individuals who have demonstrated outstanding achievements in academic and extracurricular activities. We are looking for self-motivated, team players who have excellent organization and communication skills. While a background in finance or accounting is not required, applicants should be comfortable with basic numerical computation. Do you have an interest in or a passion for solving complex business problems? At CME Group you will be focusing on fundamental business issues - managing risks, increasing revenues, controlling costs and offer an opportunity to work side by side in our world class facilities with our extremely talented team who work on cutting edge technology paired with the challenging demands of the intensive world of a financial exchange. The kind of tasks interns can look forward to would be a range of opportunities like - Create tools/solutions to automate/streamline critical business process or new business needs. Support the Quant Risk Team (QRT) to build research analysis tools for different risk models, with monthly BAU tasks and reporting. This includes for example preparing monthly reports for regulators. Understand the basics of Enterprise Risk management, provide remediations and compensating controls recommendations. Work for Pricing and Valuation team in OTC Settlements space and ideating for next generation solutions around this. Understand the CME product and service launch workflows. Work on automating various compression tools. During your internship, you can meet a variety of people, allowing you to form relationships, you can build on in the future. Certain Individuals who excel in their field will accompany you as Mentors throughout the course of the internship. The internship will expose you to our culture at CME Group and provide you with a knowledge base to draw upon throughout the remainder of your internship and beyond. Principal Accountabilities Ensure that the assigned tasks are completed on time with impeccable quality. Education Attend a Bachelors in engineering /Bachelors in Science (Maths / Statistics majors only) / Masters/ PhD course in a finance/mathematics related subject. Experience While a background in finance or accounting is not required, you should be comfortable with numerical computation and have a demonstrable interest in working in financial services. Software Requirements Atleast one programming skills Java Script, App Script , CSS , HTML, Python, VBA, R, Tableau, Looker Oracle, SQL Server , PL SQL, Non - Essential Any knowledge of Applied mathematics / calculus / economic theory / statistics would be helpful. Any background in Financial Engineering would be very useful . Algorithms, Pseudo codes, DB Queries (Joins and Views), Problem-approach . Physical, Scheduling, & Location Requirements Duration Apr - Jun 2025 40 hours per week Need to be on site for work in the CME Bangalore Office
Posted 2 months ago
15 - 20 years
16 - 18 Lacs
Vadodara
Work from Office
Role & responsibilities Responsible and Accountable for maintaining production schedule and outputs. Investigate customer complaints. Develop, recommend and monitor corrective and preventive actions. Identify training needs and organize training interventions to meet quality standards Coordinate and support on-site audits conducted by Customers. Evaluate audit findings and implement appropriate corrective actions. Responsible for document management systems. Assure ongoing compliance with quality and industry regulatory requirements. To participate in Management Review Meeting. Preferred candidate profile BPharm / BSc with minimum 15 years of experience in pharma industry. Experience in formulation, primary packaging sector preferred.
Posted 2 months ago
4 - 9 years
6 - 7 Lacs
Bengaluru
Work from Office
Aragen 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.
Posted 2 months ago
1 - 4 years
0 - 2 Lacs
Ahmedabad
Work from Office
Department - Quality Assurance Designation - Officer ( Vendor Qualification) No. Of Vacancy - 1 (Male) Qualification B. Pharm / M. Pharm Required Experience - 1 3 Years Industry - Pharma (Formulation) Key Roles ( As per JD) Review of stability related to quality control. Review of SOPs and internal calibration records. CAPA verification related to quality control units. To perform the risk assessment of the quality control and plan the mitigation in coordination to quality head. Department - Quality Assurance Designation - Officer ( IPQA) No. Of Vacancy - 9 (8 Male, 1 Female) Qualification - B.Pharm / M. Pharm / M.Sc Required Experience - 1 - 3 Years Key Roles ( As per JD) Procedure and verify incoming Raw Materials as per approved vendors, clean area environment monitoring data, reconciliation of the rejections at filling, sterilization and packing stage, prepare and perform visual inspection, documentation (batch records, Logbooks) Regards, Darshana cv.naukri@evokehr.com
Posted 2 months ago
3 - 7 years
3 - 7 Lacs
Bengaluru
Work from Office
Responsible for strategic, tactical and operational quality planning Ensuring all products supplying to customers meet their requirements Establish, publish and maintain polices and procedures related to the scope of QA activities Preparing, reviewing, approving and distributing of all quality related documents Ensure in-process documentation complies with standard operating procedures (SOPs) and quality standards Monitor and document various stages of the manufacturing process to maintain sterility and quality. Conduct regular quality checks on production lines and ensure adherence to Good manufacturing Practices (GMP). Assist in preparing and reviewing batch manufacturing records and reports. Participate in internal audits and help identify areas for improvement in the QA process. Collaborate with other departments to ensure smooth documentation flow and compliance. Report any deviations or non-conformance issues to senior management for timely action. Ensure proper maintenance and calibration of laboratory and production equipment. Assist in training staff on QA procedures and documentation practices. Support product release by ensuring that all quality control checks are in place.
Posted 2 months ago
18 - 22 years
18 - 22 Lacs
Chennai
Work from Office
Greetings!!!! We are seeking for a QA Manager role - for Global API Manufacturing company at Chennai. Responsibilities: Responsible for Quality of products manufactured & QMS requirement at manufacturing site • Perform Gap analysis at regular interval to identify any gaps in quality system with respect to change in SOP, updating in pharmacopeia, change in any regulatory guidelines etc, and to inform Head QA to prepare & implement action plan as per guidance of Head QA. • Follow & establishment good documentation and filing system for easy retrieval & maintenance of all quality records Monitor Change control management and review the monthly data on change control status. Review and approval of Change controls, documentation and associated CAPAs and Provide Change control status for site quality management review meeting. • Management of Deviations and CAPA investigations and Periodic review of CAPA status with all concerned for timely closure of the same. • Handling of Out of specification, out of trend results and Customer complaints logging, investigation and Ensure timely closure of CAPA for the same. • Preparation of Annual product reports and Vendor Qualification of Raw Materials & Packing Materials with respect to Vendor Questionnaire Verification, Vendor Audit and Compliance Report Verification prior to Approval. • Review of all validation protocols and reports like process validation, cleaning validation, purified water, WFI validation, & Equipment Qualifications. • Review of online batch records review for all stages of manufacturing & packing activities. • Meeting all the delivery schedules for the products as committed in the Plan. Co-ordination with Research team, Quality Control, Engineering and Warehouse functions to ensure compliance to the committed Plan. • Active participation for timely installation, commissioning and validation of all the equipments and processes in the API Manufacturing facility. • Maintaining and up keeping the area as per the cGMP and Regulatory requirements and putting continuous efforts for improvement in quality and Productivity. • Co-ordination during the execution of Validation batches & process stabilization activities of various APIs & Intermediates. • Co-ordination in Quality Risk Management with various departments and Involving in HAZOP studies of various products to address the EHS issues before to Adopting in plants with safety department. • To ensure implementation and propagation of all EHS norms so as to create safe working Environment.Compliance to 5S and OE documentation. Tamil Speaking is Must Interested candidates kindly share your updated cv to uma@bvrpc.com
Posted 2 months ago
4 - 9 years
3 - 8 Lacs
Ahmedabad
Work from Office
Roles and Responsibilities (Hiring for AQA Role, IPQA Role, QMS Role - API Background is Must) Ensure compliance with GMP, BMR, BPR, SOPs, and quality systems. To Perform Analytical QA Role IPQA Activities QMS Activities Validation Activities Collaborate with cross-functional teams to ensure timely completion tasks Person Should be from the API Background
Posted 2 months ago
4 - 6 years
3 - 5 Lacs
Hyderabad
Work from Office
Role & responsibilities 1. Reporting to reporting manager and assist him in Quality Assurance activities. 2. Responsible for IPQA activities. 3. Responsible for giving Line clearance to Equipment/Area. 4. Responsible for monitoring packing and repacking of API and intermediates as per BPR and PO. 5. Responsible to Plant round for online compliance. 6. Responsible for review of batch manufacturing sheets. 7. Responsible for Review of the batch release documentation. 8. Responsible for supporting to customers, regulatory audits. 9. Responsible for Preparing & Reviewing of quality system related documents like SOPs, BMS, Formats, registers, compilation of validation protocol and reports etc. 10. Documents Control and Issuance i.e., SOPs, BMS, Formats, registers, specifications and Method of analysis, compilation of validation protocol and reports etc. 11. Responsible for Preparation & review of Annual product review (APQR). 12. Responsible for Preparation & review of Validation protocol and reports. 12. Additionally, responsible for to carry out any work assigned or delegated by HOD/Designee Quality Assurance
Posted 2 months ago
4 - 5 years
1 - 4 Lacs
Vadodara
Work from Office
STAR PLAST INDUSTRIES PVT LTD is looking for Quality Officer to join our dynamic team and embark on a rewarding career journey Planning and designing test cases and test scenarios to validate the functionality and performance of software and systems Executing manual and automated tests to identify and document defects Debugging and troubleshooting software and systems to resolve any issues and improve their reliability Collaborating with cross-functional teams, such as software developers and project managers, to ensure that the software and systems are of high quality and meet the needs of the business Creating and maintaining documentation to ensure that the testing process, results, and defects are well understood by others Should be detail-oriented, have excellent problem-solving and communication skills Experience : The candidates must have 4 to 5 years of rich experience in plastic injection and blow moulding processes
Posted 2 months ago
2 - 5 years
4 - 8 Lacs
Kolkata
Work from Office
S.K.AGARWAL&SON. 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. Good Presentation, Communication and Reporting Skills. Working Knowledge of Computers and Accounting Software. Strong inter-personal skills to deal with Clients and Team Members
Posted 2 months ago
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