45 Apqr Jobs

To ensure the GMP and GLP compliances. To participate in OOS, OOT, Deviation and complaint investigation, root cause analysis and to review investigation report. To carry out closure activities. To compile data provided by manufacturing, warehouse, QC for preparation of complaint investigation report. To prepare and review trends of OOS, OOT, Deviation, complaints, customer audit/inspection. To initiate change controls pertaining to QA and to review change controls of other departments w.r.t impacted activities. To review change control trend. To compile data for and prepare, review risk assessment reports w.r.t. Deviation, OOS, OOT, Nitrosamine impurities, elemental impurities, etc. To appr...

Role & responsibilities Suggested position: Sr Manager / Manager Education: Post Graduation (Life sciences preferred) Total Exp: 15-17 Years (Biopharma is preferred) Others: Ready to support in different shifts Responsibilities: Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends Conduct Gemba walkthroughs in QC department and to ensure quality compliance. Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented. Responsible for preparation and review of documents SOPs, P...

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, E...

Dear Candidate, THINQ Pharma is currently seeking a QA-QC professional for the Pitampur location. As a QA-QC specialist, you will be responsible for reviewing and controlling all Quality Management System (QMS) related documents such as change control, deviations, out of specification cases, Corrective and Preventive Actions (CAPA), and incidents. Additionally, you will review master Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), Standard Operating Procedures (SOP), and specifications. Your role will also involve participating in internal audits, coordinating for compliance and closure, conducting root cause and risk assessments, and reviewing and maintaining various exec...

Authorized, Responsible and accountable for Analytical check in QC To Conduct In process Quality Assurance check for the Quality Control and follow up for the Corrective Actions. Review in process, finished product ADS and FP COA. Review and release of raw material and affixing of the the labels. Microbiology In process checks, review of water trends, EM trends. Chemistry water trends. Stability Protocol and report review. Regular monitoring of Stability and issuance of ADS. Back up review of Stability data. Review of protocols and reports and follow up for the closure. OOS, LIR, OOL & OOT Handling as per respective SOP. Audit Trial review SOPs/STPs/Specs: Preparation and review of SOPs for ...

Role & responsibilities 1. Managing the quality documents and conducting internal Audit & data review etc. 2. Maintaining all records and documentation as per 17025:20053. 3. Maintaining regularly and tracked calibration and standard log books, 4. Directing all quality activities for the laboratory such as ILC, IQC, Training, etc. 5. Preparing compliance report for the audit or for the closure of various shortcomings or NCs. 6. Having sound knowledge of QMS and LIMS. 7. Knowledge of 21cfr, OOS, Market complaints, APQR.

Role & responsibilities Complete knowledge of Validation ( AHU / Autoclave / Dry Heat Sterilizer etc ) and Calibration -Capable of Compiling the Validation and calibration Activities -Good Computer Skill Preferred candidate profile CLEAN SHAVEN MALE CANDIDATE WITH MINIMUM 2-3 YEARS EXPERIENCE IN STERILE INJECTION SECTION

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also...

As a member of the ACG Corporate team, your primary responsibilities will include preparing and conducting tests such as MLT and Water analysis in the Micro Lab. It is crucial to ensure proper documentation and to develop and establish testing procedures. Maintaining accurate records, keeping the work space organized, and fostering a quality culture across the plant are essential aspects of this role. Additionally, you will be responsible for establishing a review mechanism to continuously upgrade and standardize processes. In the functional core of your role, you will be required to review customer quality complaints, which involves investigating complaints, conducting root cause analysis, ...

As a member of the ACG Corporate team, your primary responsibilities will include preparing and conducting tests such as MLT and Water analysis in the Micro Lab. It is crucial to ensure proper documentation, develop and establish testing procedures, maintain accurate records, and uphold a clean work space. Your role will also involve fostering a culture of quality across the plant and implementing a review mechanism to consistently enhance and standardize processes. Within the functional core of your responsibilities, you will be expected to review customer quality complaints, conduct complaint investigations, perform root cause analysis, and identify Corrective and Preventive Actions (CAPA)...

Ensure compliance with cGMP guidelines Batch Manufacturing Record preparation Packaging Material Specification Preparation APQR New drug application Batch card preparation Endorse documents preparation Required Candidate profile Experience in Quality Assurance of 5 years Gender Male

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 10 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing proc...

Role & responsibilities Handling the Change Control Programme and functional Change Control Coordinator. Handling of Deviation and Market Compliant. Preparation and review of Annual Product Quality Review. Preparation, maintenance, reviews of all other QMS documentation. Handling of RM/PM rejection documents. Preparation and issuance of SOP's. Preparation, Review and Execution of Process Validation Protocol and Report. To Collect and send sample to QC for analysis. To release the product for next stage after receiving QC release report. To maintain logbook and document control. Issuance of format. Reviewing of BMR / BPR. Ensure the implementation and compliance with cGMP aspects. Ensure comp...

As the Quality Control Officer, you will be responsible for ensuring the overall quality of products and compliance with GMP at the site. This includes conducting line clearance prior to dispensing, manufacturing, packing, and validation activities. You will also be involved in sampling during the manufacturing of validation, exhibit, and commercial batches, as well as in-process control, routine inspection, and online process verification and documentation. Your duties will involve the preparation, review, and approval of various documents such as SOPs, BMRs, BPRs, SMFs, VMPs, APQRs, MFR validation protocols/reports, and qualification protocols/reports. Additionally, you will be responsible...

Implement & maintain quality systems in compliance with cGMP & regulatory norms.batch review, product release,change control,QA documentation,audits, manage deviations, CAPA,OOS investigations.quality metrics & APQR & regulatory inspection readiness.

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certi...

Implement and maintain QMS per GMP. Conduct audits, vendor qualification, and quality reviews. Approve SOPs, BMRs, BPRs, specs, change controls, APQRs. Investigate OOS, OOT, complaints, oversee CAPA, and ensure compliance across all departments. Required Candidate profile QMS Implementation | cGMP Compliance | Internal & External Audits | SOP/BMR Review | Change Control | CAPA | APQR | Risk Assessment | Vendor Qualification | Regulatory Compliance | Root Cause Analyse

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing proce...

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coo...

Job Title: Executive - Senior Officer - Quality Assurance Department: Quality Assurance Location: Vadodara Experience: 4 6 years Qualification: B.Pharm / M.Pharm Job Summary: The Executive Quality Assurance is responsible for ensuring compliance with cGMP standards through effective execution of Validation, Annual Product Quality Review (APQR), and Quality Management System (QMS) activities. The role involves coordination with cross-functional departments, documentation management, and continuous quality improvement. Key Responsibilities: 1. Validation: Prepare, review, and execute validation protocols and reports (Process, Cleaning, Equipment, HVAC, Utilities, etc.). Ensure timely qualifica...

Opening with an leading Pharma Company. Role & responsibilities : Continuous process Monitoring Batch Release of Finished product Collection of Sample ie in-process, Finished Product , Control, Stability and Tendor Knowledge of Collection of Validation samples i.e process validation, cleaning and hold time validation. Knowledge of review of Master and executed MFR/BMR and MPR/BPR Adequate knowledge of Inprocess checks of Tablet ,Capsule ,Liquid and Ointment. Adequate knowledge of Shop floor related Non-compliance ,its root cause and compliance. Adequate knowledge of calibration of instruments ie weighing balance , friabilator, DT apparatus, hardness tester, Vernier calliper, Moisture analyze...

Job Responsibilities Sr. Executive Quality Assurance Headquarter: New Delhi/Faridabad Purpose of the Position :- To ensure document & data control activities are performed as per approved QMS. Job Responsibilities: 1. Responsible for document and data control activities related to QMS. 2. Responsible to do issuance of all prepared documents and retrieve all superseded documents. 3. Responsible to update all master document list as per requirement. 4. Responsible to update document tracking system. 5. Responsible to maintain all QA logbooks. 6. Responsible to do timely issuance of controlled logbooks, formats and other required documents to all departments as per requirement. 7. Responsible t...

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...

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier...

1. Managing the entire QA and QC activities in the plant. 2. Monitoring, Documentation and implementation of process development. 3. Making sure that there is satiability data to support retest or expiry dates and storage conditions on APIs and /or intermediates where appropriate; and performing product quality reviews. 4. Reviewing completed batch production and laboratory control records of critical process steps before release of the API intermediated for distribution 5. Making sure that critical deviations are investigated and resolved. 6. Approving all specifications and master production instructions, Test methods, Qualifications. 7. Approving all procedures impacting the quality of in...