71 Apqr Jobs

As a Quality Assurance Manager, your role involves ensuring quality standards for all products and manufacturing activities. Your key responsibilities will include: - Ensuring GMP compliance throughout the facility - Organizing, educating, and executing activities as per Quality Assurance objectives - Handling customer audits - Releasing or rejecting APIs and Intermediates - Ensuring workforce motivation and alignment with Company objectives - Handling OOS investigation - Ensuring compliance of QMS/GMP/GLP - Managing Regulatory audits and compliance (USFDA/EU/TGA/WHO/Cofepress/KFDA) - Knowledge and handling of Risk assessments, cleaning validation, Preparation of site master file, Quality Ma...

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

Role Overview: As a part of ACG Corporate, your role will involve preparing and carrying out tests such as MLT and Water analysis in the Micro Lab. You will be responsible for ensuring proper documentation, developing and establishing testing procedures, maintaining proper records, and work space. Your key responsibility will be to develop and sustain a quality culture across the plant and establish a review mechanism to constantly upgrade and standardize the process. Key Responsibilities: - Review customer quality complaints, including complaint investigation, root cause analysis, and identifying the Corrective and Preventive Actions (CAPA). - Ensure closure of complaints within defined tim...

protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately

(QMS) implementation, Manage Change Control, Deviations, and CAPA to maintain product quality. Conduct Vendor Qualification & audits. Ensure GMP practice. Stability Studies & ensure compliance with ICH guidelines. Time Studies & process optimization.

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...

As a member of ACG Corporate, your primary responsibilities will include: - Prepare and carry out tests like MLT, Water analysis etc in Micro Lab - Ensure proper documentation - Develop and establish testing procedures - Maintain proper records - Maintain work space - Develop and sustain Quality culture across the plant - Establish a review mechanism to constantly upgrade and standardize the process In your functional core role, you will be responsible for: - Reviewing customer quality complaints (includes complaint investigation, root cause analysis and identifying the CAPA) - Ensuring closure of complaints in defined timelines with implementation of CAPA - Ensuring sustainability of QMS (D...

To handle issue control of all SOP, formats, documents, log books, registers, bound book and retrieval, archival of document and records related to all department. To handle e for control of documents at site. To handle for Preparation and Review of Standard operating procedure, handling of archival room. Responsible for Issuance and review of Batch Manufacturing Record and Batch packing record. Responsible for compilation of APQR Responsible for performing IPQA checks and ensuring compliance. Responsible for product inspection, container sealing, Inspection of production consumable and Filter bags. Responsible for handling of Dispatch activities. Responsible for handling cleaning validation...

Key Responsibilities: Preparation, review, and control of Master Formula Records (MFRs) and Batch Manufacturing Records (BMRs). Identification, drafting, review, and periodic revision of Standard Operating Procedures (SOPs) across departments. Compilation and preparation of Annual Product Quality Review (APQR) reports. Preparation, review, and execution of Qualification & Validation documents (equipment, utilities, process, cleaning, etc.). IPQC management ensure in-process checks are conducted as per defined procedures and documented appropriately. Ensure timely product release as per defined process and quality requirements. Work on company-wide quality strategies aimed at reducing non-com...

1. Line clearance in dispensing, manufacturing and packing area 2. In -Process Quality Assurance activities, sampling, analysis and AQL during production. 3. To ensure stage wise completeness of BMR during production. 4. Monitoring of environmental conditions in production area. 5. Coordination with other departments for smooth running of the plant. 6. Calibration, verification and maintenance of IPQA instruments. 7. To monitor process as per technical directions. 8. To fill all IPQA sampling logs in time. 9. To ensure deviations are properly documented and CAPA implemented. 10. To withdraw samples at different stages of In-Process and finished product as well as validation samples as per TD...

Job Title: Sr. Executive / Assistant Manager Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 8 to 10 years of similar experience in a regulatory-approved OSD manufacturing large unit. Job Responsibilities & Accountabilities We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities. Key Responsibilities Lead deviation and market complaint investigations, with timely CAPA execution Ensure effective implementation and tracking of CAPAs from deviations & complaints Review Batch Manufacturing & Packing Records, APQR, and SOPs Manage Change Controls, V...

Responsibilities: Documentation & Record Review: Review specifications, sampling instructions, test methods, and analytical reports. Review and approval of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR), and Equipment Qualification Records. Review completed Batch Production Records and Laboratory Control Records post-batch completion. Review analytical data, Calibration & Preventive Maintenance schedules, and external audit reports. Review and finalize Certificate of Analysis (CoA) for finished products. Review Draft Equipment Cleaning Records and Hold Time Study protocols/reports. Review Standard Operating Procedures (SOPs) and Annual Product Quali...

Responsibilities: To impart the departmental training & co-ordinate for cGMP training as per planned schedule. To Coordination of Regulatory/Customer audit and its compliance. Review the audit feedback and provide the action plan for compliance of audit observation/ findings. To perform self-inspection for all respective departments & evaluate the compliance of any reported non-compliance in the self-inspection report. To review the deviation, change control, incident for impact on product quality and safety in QAMS. Perform risk assessment for risk reduction/mitigation at acceptance label for product & QMS related documents as part of impact assessment. Review of QA documents, review of spe...

Date: 15 Sept 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Development Services Job Title: Sterile Manufacturing, Filling Supervisor Department: Formulation production Job Location: Bengaluru, India About Syngene: Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit. M...

Responsibilities: Conduct HPLC, GC, UV, water analyses per BMRR. Implement change controls, manage deviations. Perform API manufacturing, intermediate handling, SRP processing.

Ensure/Verify—batch release, SOP compliance, GMP & documentation control Record & review—all production and Engineering & Maintenance activity & related QMS Conduct—Audits, gap analysis. Prepare—DMF, CTD, VMP, SMF, protocols Required Candidate profile QA lead—oral solids SOP/GMP & doc control QMS—deviations/CAPA/CC/complaints, root cause investigation APQR process/cleaning validation & CSV IQ/OQ/PQ & calibs stability & summaries auditing DMF/CTD

Role & responsibilities APQR Preparation & Management: Collect, compile, and analyze data from various departments (Production, QC, QA, Warehouse, etc.) for APQR. Ensure timely preparation and completion of APQRs for all marketed products. Review trends in product quality, deviations, complaints, OOS/OOT results, and change controls. Compliance & Documentation: Ensure APQRs are prepared in accordance with GMP guidelines (e.g., USFDA, & EU). Maintain accurate and complete documentation of APQRs and related records. Coordinate with regulatory affairs for submission of annual reports when required. Cross-Functional Coordination: Liaise with Production, QC, QA, and other departments to gather ne...

Quality assurance, Change management, Change control, APQR's, Media fill, Microbiology Compliance and Documents handling in software

Role & responsibilities 1. Line Clearance in all stages. 2. Sampling all stages. 3. Validation. 4. Control Sample Management 5. APQR 6. QMS Review. Interested Applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9867700982

Role & responsibilities Monitoring of preventive maintenance, Calibration, HVAC Validation and other Schedules Review of Temperature Mapping, Calibration Certificates Ability to handle Process, HVAC Validations and Equipment Qualifications Monitoring of Filter Cleaning and Differential Pressure of AHU's Review of Water and Environmental Trends Monthly and Yearly Handling of trackwise for QMS related activities Handling of Compliance wire for training related activities Preparation & Review of Annual Product Quality Review reports APQR Experience in handling audits Reviewing of Calibration schedule, Preventive maintenance schedules and Equipment qualification protocols and reports Reviewing o...

We have urgent Requirement for : Department : Quality Assurance Designation : Executive Skills Required : Process Validation, Equipment Qualification, QMS, APQR, Capa, Cleaning Validation. Experience Required : 03 to 08 years Salary : Depend upon Interview Location : Nalagarh interested candidate can contact @ 7717304694 or can send their Resume at hr2@theonpharma.com

You will be responsible for the following tasks as Officer - API at Dishman Carbogen Amcis Limited in Bavla, Gujarat, IN: - Handling Manufacturing Compliance activities such as IPQA Activity - Managing QMS Documents including CAPA, OOS, and Change control - Handling APQR processes - Managing Batch release activities - Demonstrating strong communication skills - Having exposure to Regulatory audits If you possess the necessary qualifications and experience for this role, you are encouraged to apply.,

Comprehensive knowledge of large-scale biotech manufacturing, covering both upstream ( fermentation) and downstream (purification ) processes. Excellence in documentation for batch records and process-related documents to ensure accuracy, traceability, and regulatory compliance. Proficient in cell bank management, including creation, storage, monitoring, and traceability for consistent production performance. Advanced understanding of Good Manufacturing Practices (GMP), regulatory standards (including FDA), and pharmacopeial requirements for biotech products. Strong communication, teamwork, and interpersonal skills to foster effective cross-functional collaboration and timely resolution of p...

Handling of QMS System (Change Control, deviations, OOS, OOT, CAPA, etc.) Validation Activities Aware of Equipment / Instruments qualifications Good Knowledge of SOP preparation & Review Good Knowledge of APQR Aware of Internal Audit Activities