Get alerts for new jobs matching your selected skills, preferred locations, and experience range. Manage Job Alerts
4.0 - 7.0 years
4 - 6 Lacs
Baddi
Work from Office
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 ...
Posted 2 months ago
2.0 - 7.0 years
2 - 7 Lacs
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 BPC...
Posted 2 months ago
1.0 - 5.0 years
3 - 4 Lacs
Vadodara
Work from Office
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 ...
Posted 2 months ago
2.0 - 5.0 years
4 - 6 Lacs
Pune
Work from Office
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...
Posted 2 months ago
6.0 - 10.0 years
9 - 10 Lacs
Bengaluru
Work from Office
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
Posted 2 months ago
5.0 - 10.0 years
5 - 9 Lacs
Ahmedabad
Work from Office
> 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...
Posted 2 months ago
4.0 - 9.0 years
6 - 16 Lacs
Ahmedabad
Work from Office
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...
Posted 2 months ago
1.0 - 3.0 years
3 - 5 Lacs
Navi Mumbai
Work from Office
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...
Posted 2 months ago
3.0 - 6.0 years
1 - 4 Lacs
Vasai
Work from Office
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...
Posted 2 months ago
1.0 - 2.0 years
3 - 4 Lacs
Ahmedabad
Work from Office
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...
Posted 3 months ago
1.0 - 6.0 years
3 - 8 Lacs
Vadodara
Work from Office
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...
Posted 3 months ago
2.0 - 7.0 years
4 - 7 Lacs
Pune
Work from Office
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...
Posted 3 months ago
8.0 - 12.0 years
6 - 8 Lacs
Hyderabad
Work from Office
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...
Posted 3 months ago
5.0 - 10.0 years
5 - 15 Lacs
Bharuch
Work from Office
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...
Posted 3 months ago
8.0 - 10.0 years
7 - 9 Lacs
Pune
Work from Office
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
Posted 3 months ago
12.0 - 16.0 years
12 - 16 Lacs
Nalagarh
Work from Office
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...
Posted 3 months ago
2.0 - 7.0 years
2 - 7 Lacs
Jhagadia, Ankleshwar
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 BPC...
Posted 3 months ago
1.0 - 6.0 years
1 - 6 Lacs
Tirupati, Chennai, Bengaluru
Work from Office
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...
Posted 3 months ago
10.0 - 20.0 years
40 - 45 Lacs
Bengaluru
Work from Office
Purpose: To process, pack, and deliver the right quality seeds to the market at the right time, at the lowest cost, and without any market complaints. Roles and Responsibilities: Coordinate with Sales and Production teams to ensure on-time delivery of seed products to the market Plan and implement seed processing strategies aligned with the targeted business plan Oversee procurement and control of consumables for processing and packing Ensure statutory and regulatory compliance across all processing locations Enforce best practices in warehouse management, including safe storage, pest control, and material handling Design and implement SOPs and work instructions for processing, packing, and ...
Posted 3 months ago
3.0 - 5.0 years
3 - 6 Lacs
Rangpo
Work from Office
Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com
Posted 3 months ago
3.0 - 6.0 years
2 - 6 Lacs
Bengaluru
Work from Office
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
Posted 3 months ago
4.0 - 9.0 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 3 months ago
1.0 - 7.0 years
4 - 8 Lacs
Gurugram
Work from Office
Level - AM/DM/MGR Position- Gurgaon Plant Educational Background - B.tech in Mechanical/ Automobile Engineering with 3 to 8 yrs experience Diploma in Mechanical/Automobile with 10 to 16 yrs experience. Job Role: Market returned parts analysis of Door components involving mechanical functional parts such as Handle, Latch, Regulator, Gas springs, Hinge, Body-In-White (BIW) components. On Field support for the escalated complaints from Service team /Dealerships. Receiving of market complaints, understanding and analysis of the complaint by close coordination with Vendor, Parts -Quality, Engineering Plant Team. Pro-active visits at Vendor end for quality improvements, identifying potential probl...
Posted 3 months ago
2.0 - 5.0 years
1 - 3 Lacs
Mohali, Chandigarh, Panchkula
Work from Office
Role & responsibilities Conducting and Documenting Internal and Refresher Trainings Training Coverage and Participant Documentation Issuance and Retrieval of QMS Formats (OOS, Change Control, Deviation, Calibration) Collection, Review, and Archival of Calibration Records Compliance with ISO/IEC 17025, ISO 17034, and ISO 9001 Requirements Issuance and Archival of Instrument Usage and Calibration Logs Preparation and Control of Master SOPs, Specifications, and STPs Withdrawal and Return of Superseded Master Documents Preparation and Distribution of TDS Masters for New Samples Preparation of Protocols and Reports for Qualification/Validation/Verification/Method Transfer Completion and Verificat...
Posted 3 months ago
5.0 - 8.0 years
13 - 15 Lacs
Hyderabad
Work from Office
Handle market complaints received from across the globe. Able to review the investigation reports received from the Novartis sites and Contract Manufacturing Organizations. Collaborate with external Supply organization, Novartis sites, Country pharma organizations for continuous improvement. Key Responsibilities: Performing day to day activities of processing market complaints assigned as per the relevant SOPs, business matrix and SLA timelines. Assist in data collection and reporting of KPIs Assist in continuous improvement initiatives. Manage ad-hoc projects assigned in area of work. Proactively report all deviations through timely escalations Implement continuous process improvement proje...
Posted 3 months ago
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Accenture
75151 Jobs | Dublin
Wipro
28327 Jobs | Bengaluru
Accenture in India
23529 Jobs | Dublin 2
EY
21461 Jobs | London
Uplers
15523 Jobs | Ahmedabad
Bajaj Finserv
14612 Jobs |
IBM
14519 Jobs | Armonk
Amazon.com
13639 Jobs |
Kotak Life Insurance
13588 Jobs | Jaipur
Accenture services Pvt Ltd
13587 Jobs |