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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 Required -Candidate should have experience in Biotech or injectable industry.
Posted 3 days 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 1 week 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 weeks 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 weeks 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 Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com
Posted 1 month 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 1 month 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 system handling experience
Posted 1 month 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 - 2-3 Years of experience in Environmental monitoring, Culture media preparation and MLT testing Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100
Posted 1 month 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 1 month 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 product quality. Collaborate with cross-functional teams (QC, Production, Regulatory Affairs, etc.) for continuous improvement. Desired Candidate Profile: Education: B.Pharm / M.Pharm / M.Sc in Chemistry or related field Experience: 10+ years of experience in Analytical Quality Assurance or QC in a pharmaceutical manufacturing environment, preferably in oral solid dosage (tablets) Hands-on experience in handling analytical investigations in a QC lab Experience in facing USFDA or other international regulatory audits Strong understanding of cGMP, ICH guidelines, and data integrity requirements Good communication and documentation skills
Posted 2 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 2 months ago
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