123 Market Complaints Jobs - Page 4

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic im...

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...

Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperat...

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 ...

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com 1.To review and implement Quality Management System for cGMP compliance at site. 2.To review and approve of product design. 3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements. 4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR 5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. 6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 7.Ap...

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

Key Responsibilities: 1. QMS Implementation & Oversight: Maintain and continually improve QMS elements such as deviation handling, change control, CAPA, OOS/OOT, risk assessments, and quality reviews . Ensure compliance with GMP, GAMP, ISO, ICH (Q9, Q10), and regulatory agency requirements (e.g., USFDA, MHRA, WHO, EU GMP) . 2. Deviation & CAPA Management: Investigate deviations in manufacturing, QC, and support areas. Perform root cause analysis (RCA) and drive timely and effective CAPA implementation. Monitor the closure timelines and effectiveness verification of CAPAs. 3. Change Control & Document Control: Evaluate and manage changes in equipment, facility, process, and documents. Review ...

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 BPC...

Position: Senior Officer Job Title: Senior Officer Job Grade: Function: Corporate Quality Compliance Sub-function: Complaints Manager s Job Title: Senior Manager-1 Skip Level Manager s Title: Function Head Title: Head of Global Quality Systems Complaints Location: Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Review of Product Quality Complaint Investigation Reports (India Market). Coordinate with other stakeholders involved in the complaint handling process. Areas of ...

Job Description 1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements. 2) Execute and supervise all tasks and activities as per the applicable SOPs. 3) Complete self-training and monitor training of team members on the relevant SOPs. 4) Report any quality concerns or suggestions for improvements to Managers. 5) Review of Master document such as Validation protocol and reports. 6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint. 7) Ensure preparation and periodic review / updation of APQR. 8) Preparatio...

1. To review and to carry out the assessment of Change control, Deviation, CAPA, OOS, Internal Audit, Market complaints & Product Recall 2. To prepare QMS trends & QMS metrics, 3. To conduct the Quality Review Meeting and coordination with CFT members. 4. Knowledge in usage of Power BI tools & QMS data Graphical representation

> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years...

Receive and Log Complaints : Record and evaluate complaint submissions from customers regarding manufacturing defects or issues. Ensure all complaints are logged accurately in the complaint management system. Investigate Complaints : Conduct thorough investigations to determine the root cause of the complaint. Coordinate with internal departments (Quality Assurance, Regulatory Affairs, Production) to gather necessary information. Communicate with Stakeholders : Communicate with customers to understand their concerns and provide updates on the investigation. Liaise with healthcare providers, if applicable, to acquire relevant complaint information. Regulatory Compliance : Ensure timely proces...

Role & responsibilities Inspection - release/rejection of incoming material against approved specification. Rejection of material non conformance review, reporting in IMSxpress. Updation of critical incoming material list (incoming material specification) based. Allocation of catalogue number to finished products depending on customization/changes in product. Control of documents (QSP, SOP, formats, MFR, MQR) issuance, retrival, archival and updation in IMSxpress. Compiling of data for MIS as per schedule Allocation of batches as per customer purchase order over mail. Review of certificate of analysis for finished products. Daily IPQA of production and BMF as per the approved protocols and p...

1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory department. 6. Working Hands on MARKET COMPLAINTS and CAPA. 7. Preparation of Master Formula Record (MFR) and Preparation Of (SOPs). 8. Preparation of EQUIPMENT QUALIFICATION documents i.e. IQ, OQ, PQ protocol and Reports during Installation of New Instruments/ Equipments. 9. Identification of Hazard and Calculat...

Followings will be the Job Responsibilities of the position holder: 1. To initiate Change Control and perform impact assessment. 2. To perform manufacturing investigations related to deviation / OOS / OOT and market complaints to identify the root cause and implementation of appropriate CAPAs. 3. To ensure the compliance of quality notifications like deviations and investigations for proper closure. Review of non-conformances, deviations, change controls, internal audits, annual product quality reviews and to perform assessment on other impacting documents and related activities. 4. Handling of Track wise software, SAP and Documents compliance software s. 5. To perform and participate in Qua...

Position: Executive Job Title: Executive Job Grade: Function: Corporate Quality Compliance Sub-function: Complaints Manager s Job Title: Senior Manager-1 Skip Level Manager s Title: Function Head Title: Head of Global Quality Systems Complaints Location: Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Review of Product Quality Complaint Investigation Reports (India Market). Coordinate with other stakeholders involved in the complaint handling process. Areas of Responsibi...

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change cont...

Role & responsibilities 1. Monitoring and Managing the Quality Management System (QMS) Oversee the effective implementation and maintenance of the QMS across all departments. Ensure compliance with regulatory standards such as GMP, GLP, and ISO guidelines. Regularly review and update QMS documentation to reflect current practices and regulatory changes. Facilitate continuous improvement initiatives within the quality system. 2. Participation in Compliance, Investigations, and CAPA Effectiveness Lead investigations into quality deviations, non-conformances, and product complaints. Implement Corrective and Preventive Actions (CAPA) to address root causes. Verify the effectiveness of CAPAs to p...

Position Assistant Manager-QA Function QA Location Bharuch;;;;;;; Reports to Head QA Summary of Job (Purpose/ objective of the job Department organogram to be enclosed) To check the Quality Assurance of the products and ensure compliance with the SOP's. Key Responsibilities (Performance Indicators) Quality professional of progressive experience with strong knowledge of Speciality Ingredient, Bulk Chemicals, Food additive/ Food supplement and API Manufacturing, Quality Management System (QMS), Qualification, Validation and other Manufacturing functions.; Documentation and Handling i.e.: Integrated Management System (IMS) (ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018), WHO-GMP, FSMS (ISO 2...

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Role & responsibilities Key deliverables Supervise compliance of cGMP and any other applicable regulatory requirement, including EH&S requirements. Complete self-training and monitor training of team members on the relevant SOPs. Report any quality concern or suggestion for improvement to managers. Execute and supervise all tasks and activities as per the applicable SOPs. To lead and guide site investigation teams to investigate the reported OOS, repeat OOT, deviations and market complaints by working closely with site CFT and operating personnel, to arrive at appropriate RCA and CAPA. To personally lead major/critical/repeat investigations and ensure proper closures. To review and share wee...

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 BPC...

Role & responsibilities Aurobindo Pharma Ltd. Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Assurance (Market Complaints / QMS / Validation / IPQA) Quality Control (GMP / GC / LCMS / HPLC) 3 Experience Required: 2 7 years (pharmaceutical manufacturing) Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: Quality Assurance Key Scope • Handle Market Complaint investigations, trend analysis and regulatory responses • Maintain site QMS: Deviations, CAPA, Change Control, Audit readiness • Execute and review Equipment / Process / Cleaning Validation documentation • Perform IPQA activities: line clearance, in-process checks, batch recor...