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8.0 - 10.0 years
7 - 9 Lacs
pune
Work from Office
Job Description Maintenance of GLP in the Laboratory Upkeep of Housekeeping in the Laboratory. Ensuring activity logs are maintained for all critical instruments /equipment’s. Timely preparation of Laboratory Documents. Timely review of analytical data generated in laboratory. Ensuring Analytical Technology transfer from transferring lab as per approved protocol. Review and approval of incident , out of specification ,out of trend report and approval of QC related activities. Involved in QAMS activities such as change control, CAPA , incidents, deviation etc. Approval of stability summery report. Timely review of Quality control procedures and initiation for up gradation of same. Compliance ...
Posted 4 days ago
2.0 - 7.0 years
3 - 8 Lacs
tirupati, ranipet
Work from Office
Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Posted 2 weeks ago
3.0 - 7.0 years
3 - 8 Lacs
tirupati
Work from Office
Issue of documents like raw data, log books and calibration records Review of daily calibration raw data related to QC instruments Distribution and retrieval of standard o[operating procedures Issuance, retrieval of specifications and test methods Review of specifications, Test methods, Qualification documents, Stability/ holding time data protocols, Analytical data. Review of Water system related documents Verifying the raw materials inward and issue registers Initiation of Deviation, CAPA and Change Control Review of Audit Trail for QC Related Instruments Review of Analytical raw data, Calibrations, Daily & Monthly Verifications
Posted 2 weeks ago
0.0 - 5.0 years
2 - 6 Lacs
hyderabad
Work from Office
Role & responsibilities Responsible for Batch release Responsible for ERP Approvals. Verification of Instrument/Equipment log books for their online entries Deliver the responsibilities assigned by HOD / designee. Review of calibration of analytical instruments and equipment. Review of audit trails and participation in internal Audits. Review of IQ, OQ, PQ of Analytical instruments and equipment. Review of volumetric Solutions, Reagents and Buffers preparation records. Responsible for review the failure investigation reports of root cause analysis. Responsible for Handling of QMS elements through Agile PLM system Responsible for cleaning verification and line clearance of dispensing booths l...
Posted 2 weeks ago
3.0 - 7.0 years
3 - 8 Lacs
tirupati
Work from Office
Issue of documents like raw data, log books and calibration records Review of daily calibration raw data related to QC instruments Distribution and retrieval of standard o[operating procedures Issuance, retrieval of specifications and test methods Review of specifications, Test methods, Qualification documents, Stability/ holding time data protocols, Analytical data. Review of Water system related documents Verifying the raw materials inward and issue registers Initiation of Deviation, CAPA and Change Control Review of Audit Trail for QC Related Instruments Review of Analytical raw data, Calibrations, Daily & Monthly Verifications
Posted 3 weeks ago
1.0 - 2.0 years
1 - 2 Lacs
mysuru
Work from Office
Greetings! I am Priyanka. We are hiring QA Trainee / Officer Off roll for A leading API Manufacturing Company. Designation: 1. QA Officer/ trainee Off Roll Salary : Take way home [no benefits. no deduction] Location: Mysore Looking forward to hear from you. Note: No Charges Thanks & Regards Priyanka [ 9518220852 || priyanka@avaniconsulting.com ]
Posted 1 month ago
4.0 - 9.0 years
3 - 8 Lacs
nagpur
Work from Office
Responsible for detailed review of Finished Products, In-Process, Raw material and Stability study analytical reports along with audit trail review of each analytical data. - Responsible for review of stability study protocols of annual batch or validation batch and ensure for charging of stability study sample. -Responsible for review of stability summary sheets of stability analytical data - Responsible for review routine monitoring data of stability chambers - Responsible for review of laboratory incidents investigations and its closure. - To comprehensively review the audit trail logs of laboratory software - To ensure the overall compliance level of laboratory as per guidelines and stan...
Posted 1 month ago
2.0 - 5.0 years
2 - 6 Lacs
hyderabad
Work from Office
We are seeking a meticulous AQA - Data Reviewer to conduct quality reviews of key pharmaceutical documents and ensure compliance with regulatory standards, including 21 CFR. The ideal candidate will collaborate with cross-functional teams to maintain document integrity and support continuous quality improvement. Key Responsibilities: Conduct thorough quality reviews of documents such as CAPAs (Corrective and Preventive Actions), change controls, and ensure compliance with 21 CFR regulations. Ensure adherence to company policies and standard operating procedures through detailed document reviews. Develop and maintain a comprehensive understanding of pharmaceutical regulatory requirements. Pro...
Posted 1 month ago
2.0 - 7.0 years
6 - 10 Lacs
padra, vadodara
Work from Office
Exciting opportunity for Quality Control professionals at our USFDA approved facility Company : Apothecon Pharmaceuticals Pvt Ltd Website : www.apotheconpharma.com Location : Dabhasa, Vadodara Experience : For Analyst - 2 - 5 Years) & (Reviewer - 5-15 Years) Department : Quality Control (Analyst & Reviewer) Designation : Officer / Executive / Senior Executives (16 Positions) Role & responsibilities : Analysis as per Planning Online Review in all shifts (Analytical data review) Documentation & GLP Activities Troubleshooting during analysis Must be from USFDA approved facility only Please submit your resume to hrd@apotheconpharma.com or WhatsApp on 6357937184 to be considered for this role. Pr...
Posted 1 month ago
4.0 - 9.0 years
4 - 7 Lacs
ahmedabad
Work from Office
Excellent job opportunity for QA - AQA Specialist in Unison Pharmaceuticals Pvt Ltd, Moraiya, Ahmedabad About us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and affordable medicines across the nation. With more than 4 decades of medical service to society, Unison is today one of the fastest-growing companies in Gujarat State. In addition to this, the company is ranked 82 among the top companies of India (Rupee wise sales) MAT March 2020. This makes Unison a distinguished company across the pharma industry. You are invited to join one of India's fastest growing pharma companies in India!! Experie...
Posted 1 month ago
2.0 - 6.0 years
2 - 6 Lacs
hyderabad
Work from Office
Roles Open: QA (QMS, Validations and AQA): Qualifications, Process/Cleaning Validation, QMS (Change Controls, Deviations, CAPA, Complaints, and OOS) RA (Regulatory Affairs): CTD Preparation/Review, Regulatory Queries, Tech Transfer Documents. Required Candidate profile QA Executive / Sr. Executive (QMS & Validations) AQA Executive / Sr. Executive (Analytical QA) RA Executive / Sr. Executive – Regulatory Affairs
Posted 1 month ago
5.0 - 10.0 years
4 - 9 Lacs
Ahmedabad
Work from Office
Role & responsibilities Roles and Responsibilities 1. Stability study documents compilation and its management. 2. Stability charging, withdrawal, trend and stability report preparation. 3. Review of DRS, Log book entry and related documentation to be make online. 4. Preparation of release COA and compilation of all related documents. 5. Provide training to new person or existing person for QC testing. 6. Preparation and review of Specification/STP/SOP/DRS/protocol/data recording sheet for QC documentation on routine basis. 7. Instrument and Equipment calibration activity. 8. QMS (change control/deviation/Incident/LIR etc.) related Activities. Desired Candidate Profile -Male Candidate Requir...
Posted 2 months ago
12.0 - 14.0 years
8 - 9 Lacs
Udaipur
Work from Office
Responsible for overall Quality control laboratory Implementation of cGMP and good laboratory practices. Handling of laboratory incident, Out of calibration and deviation investigation. Conducted investigations on product/material test results failures and out of trends Review & approval of standard test procedure, specification Handling of laboratory incident, Out of calibration and deviation investigation. Making sure that all deviation, OOS,OOT, incident are investigated and closed before the release of the batch/material
Posted 2 months ago
2.0 - 7.0 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
1.0 - 4.0 years
2 - 4 Lacs
Ahmedabad
Work from Office
Strong 1-4 years of knowledge and Experience in Analytical QA
Posted 2 months ago
7.0 - 12.0 years
5 - 10 Lacs
Hyderabad/ Secunderabad
Work from Office
Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...
Posted 3 months ago
14.0 - 20.0 years
15 - 25 Lacs
Hyderabad
Work from Office
Handling CDMO customers, meetings, calls and supplying data and documents in time. Handling QMS : Change controls, deviations, OOS/OOT investigations, complaints etc. Facing Regulatory and customer audit. Single point of contact for all CDMO clients Knowledge of Analytical techniques. Handling sections like, AQA, Document review team, document issuance and archival teams, dispatch teams. Handing DI investigations Conducting periodic reviews of QMS ( PQR), monthly site review , reporting monthly MIS data Handling New product introductions Analytical and process Teach Transfers. Manufacturing compliance and handling IPQA team. Collaborating CFT e.g. Production, QC, R&D, Project Management, SCM
Posted 3 months ago
4.0 - 8.0 years
3 - 7 Lacs
Akola
Work from Office
Role & responsibilities Responsible for following activities: a. Verify cGMP, GDP, GLP and data integrity practices, compliance in Quality Control and microbiology laboratory. b. Review of Specification, Standard test procedures and test data sheet for adequacy and accuracy. c. Review Validation and calibrations of all Instruments. d. Review of AMV, AMT Protocols and reports. e. Handling of Lab incidents, Deviations, OOS, OOC, OOT etc. f. Handling of reserved sample of finished products and its visual inspection. g. Review of trend data of environmental monitoring, water analysis. h. Participation in audit the contract testing laboratory. Preferred candidate profile ERP/ QMS/QC software syst...
Posted 3 months ago
2.0 - 7.0 years
0 - 0 Lacs
Hyderabad
Work from Office
Dear All, We are conducting Walk-In Interview on 13th June 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: AQA - 6-8 Years of experience in Analytical QA IPQA - 2-4 Years of experience in Line Clearance activities for Production, Warehouse and Dispensing of Raw Materials Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, HPLC and Dissolution instruments Microbiology -...
Posted 4 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 4 months ago
11 - 15 years
10 - 15 Lacs
Chennai
Work from Office
Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and p...
Posted 4 months ago
2 - 5 years
3 - 5 Lacs
Pune
Work from Office
Analytical QA Reviewer - Officer: Looking for a candidate with 2 to 4 years of work experience as QC analyst / AQA reviewer in reputed pharma companies. Should have Knowledge of handling/ analytical data review of HPLC , FTIR , UV spectrophotometer , KF Autotitrator , Dissolution apparatus. Have Basic knowledge of CGMP , GDP , Data integrity . Should have Basic knowledge of OOS (Out of specification), OOT, OOC
Posted 4 months ago
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