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2.0 - 7.0 years
2 - 6 Lacs
umbergaon
Work from Office
Quality Assurance & Control: Maintain quality management systems (QMS) in compliance with ISO 9001, BRC, GMP, or other relevant industry standards . Monitor and enforce quality control processes throughout the manufacturing cycle, from raw materials to finished goods. Conduct regular inspections, audits, and quality checks on production lines to ensure adherence to specifications. Establish quality KPIs (e.g., defect rates, customer complaints, process capability) and ensure continuous improvement in product quality. Lead root cause analysis (RCA) and corrective/preventive action (CAPA) for quality issues, working closely with cross-functional teams. Supplier & Customer Quality Management: C...
Posted 1 week ago
0.0 - 2.0 years
0 - 3 Lacs
ahmedabad
Work from Office
Adherence to Good Laboratory Practices (GLP) and Standard Operating Procedures (SOPs). Support internal audits of laboratory processes and documentation. Ensure proper documentation and traceability of samples, reagents, and instruments. Help maintain calibration and validation records of lab equipment.
Posted 2 weeks ago
9.0 - 12.0 years
8 - 15 Lacs
baddi
Work from Office
Key Responsibilities: Manage all Analytical Quality Assurance (AQA) activities. Review, approve, and close Quality Management System documents related to QC. Act as Single Point of Contact (SPOC) for submission activities Dossier, Regulatory, Variation filings. Handle customer communications related to QA. Review manufacturing, packing, analytical reports of submission/validation batches. Review Stability data and ensure submission compliance. Ensure compliance of Stability Studies and Control Sample Handling at site. Ensure adherence to GDP/GLP. Monitor compliance of Gowning/De-gowning in QC lab. Authorize written procedures, amendments, and related documentation. Ensure SOP compliance acro...
Posted 2 weeks ago
10.0 - 15.0 years
10 - 15 Lacs
dera bassi
Work from Office
Preferred candidate profile Candidate must be from API/Bulk Drugs/ Chemical Industry. Role & responsibilities Quality System Management: Develop, implement, and maintain quality assurance policies and procedures in line with cGMP, ISO, and other relevant regulatory standards. Team Leadership & Mentoring: Lead, manage, and train the QA team, fostering a culture of quality and continuous improvement. Process & Product Quality: Oversee quality testing activities, analyze quality trends, identify non-conformities, and ensure the final API product meets high-quality standards. Supplier Quality Management: Provide Quality oversight of external vendors, assess supplier qualifications, and manage AP...
Posted 3 weeks ago
18.0 - 22.0 years
18 - 22 Lacs
indore, madhya pradesh, india
On-site
Develop and implement a strategic vision for the QA function aligned with the company's overall business goals. Provide leadership and direction to the QA team, ensuring a consistent and integrated approach to quality management. Develop, implement, manage, audit and maintain GMP quality systems. Coordinate and perform all vendor qualification and compliance Should have well versed with handling of Regulatory Audits, APQR, OOS, OOT, Investigation, Laboratory Compliances, HVAC & Water Qualification & Validation, IPQA, Lab QA, Validation & Qualification and QMS. Develop, manage and maintain a GMP compliant document control system. Oversee investigations of all non-conformances (deviations, err...
Posted 3 weeks ago
3.0 - 5.0 years
3 - 6 Lacs
vadodara
Work from Office
Role & responsibilities Review of batch manufacturing record, analytical raw data, certificate of analysis, and conformity of compliance. Review of QMS documents like CAPA, Change control, Deviation, Investigation, OOS, OOT, Lab Incident, Events, Oversight observations. Risk Assessment, trending and Audit related Activities. Coordination with Contract manufacturing organization team and Alembic internal team for QMS related activities like change control, Deviation, OOS, OOT, lab Incident etc. Review stability protocol, Stability Data Review-Protocols, Summary Sheet. Preparation and review of SOPs and Quality agreements. Management of vendor qualification and relevant documents review. Inves...
Posted 1 month ago
4.0 - 6.0 years
3 - 6 Lacs
panvel
Work from Office
Conduct routine,non-routine analyses of in-process materials, raw materials, packaging material,water samples, finished goods, stability samples.Interpret test results, compare them to established specifications control limits, make recommendations Required Candidate profile Perform visual inspections of finished products/raw material/packaging materialVerify accuracy,completeness laboratory test data, perform appropriate analyses Calibrate, validate,maintain laborator.
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
7.0 - 12.0 years
5 - 8 Lacs
bengaluru
Work from Office
Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on ...
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a member of our team, you will be responsible for ensuring data integrity within the laboratory by implementing quality management systems, conducting internal audits, and ensuring compliance with regulatory standards. Your primary focus will be on maintaining the accuracy, reliability, and security of all data generated in the laboratory. In this role, you will work closely with various stakeholders to establish and maintain quality assurance processes that support the overall quality management system. You will also be responsible for identifying areas for improvement and implementing corrective and preventive actions to address any non-conformances. A key aspect of your role will be to...
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
1.0 - 6.0 years
2 - 5 Lacs
savli
Work from Office
Role & responsibilities To support R&D Executives for all activities as directed • maintain cleanliness of testing equipment • Support chemist in maintaining the records at stipulated & confined area • Provide samples for Testing of incoming RM from trucks Take samples as per given directives from QC chemists • Provide production samples for lab testing • Maintain General Housekeeping of QC Support ISO documentation and filing. 5s, kaizen
Posted 1 month ago
6.0 - 9.0 years
7 - 9 Lacs
nalagarh
Work from Office
Role & responsibilities In-depth knowledge of microbial techniques such as sterility testing, BET, Preservative Efficacy Test, Microbial Limit Test, Culture Identification, Growth Promotion Test, and Environmental Monitoring programs. Proficient in soft skills and tools including MS Word, Excel, PowerPoint, LIMS, and MINITAB. Skilled in trend data analysis using MS Excel, including histogram plotting, use of formulas, hyperlinks, and other advanced functions. Excellent written and verbal communication skills in English. Experienced in regulatory audits and interactions with inspectors as an SME for agencies such as US-FDA, MHRA, TGA, EU-GMP, ANVISA, Ukraine, and PIC/S. Preferred candidate pr...
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
0.0 - 3.0 years
1 - 1 Lacs
Kolkata
Work from Office
Responsible for overall administration and oversight of quality control, quality assurance, and quality improvements at testing laboratory Quality Assurance Laboratory Professionals ( LAB QA) Develop and implement quality assurance protocols, Lead teams in addressing quality-related issues Bachelor degree in Medical Laboratory Technician / M. Sc
Posted 2 months ago
2.0 - 7.0 years
3 - 7 Lacs
Pimpri-Chinchwad, Kurkumbh
Work from Office
Walk-in Drive for API-Quality roles!!! Walk-in Dates: Friday July 25 & Saturday July 26, 2025 Time: 1000 hrs. to 1600 hrs. Address: Emcure Pharmaceuticals Ltd. D-24, M.I.D.C., Kurkumbh, Tal- Daund, Dist.- Pune, PIN- 413 802, Maharashtra, India. API-Quality Control M.Sc. (Analytical / Organic Chemistry) with 2-5 years of experience in Expertise in handling RM, intermediates & Finished products in API manufacturing. Handling HPLC, GC, LCMS, GCMS, ICPMS, Particle Size analyzer, and hands-on experience on Empower 3 & Chromeleon software preferred. API Quality Assurance- QMS & IPQA M.Sc. (Organic Chemistry, BE/ B. Tech- Chemical Engineering) with 2-8 years of experience in Must have experience in...
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
0.0 - 5.0 years
1 - 4 Lacs
Paonta Sahib, Chandigarh, Solan
Work from Office
Role & responsibilities We are seeking a diligent and experienced QA & QC & production. The successful candidate will Ensure that our products meet specified quality standards. This role involves managing both Quality Assurance ( QA ) and Quality Control (QC) processes, conducting inspections, and implementing improvements to maintain and enhance product quality. Expanding role in building a team of QA/QC executives. Salary Range: 15,000 to 25,000 (negotiable based on experience & skills) Experience: Minimum 2 years in QA/QC department of Tablet & Capsule or pharma manufacturing unit Preferred candidate profile Quality control analyst Responsible for testing and analyzing pharmaceutical prod...
Posted 3 months ago
3.0 - 7.0 years
4 - 5 Lacs
Oragadam, Chennai
Work from Office
Handle key QA TASKS focusing on MANUFACTURING PROCESS (IM, BM, EXTRUSION etc) QUALITY, PRODUCT AUDIT, IN PROCESS QUALITY, AUDIT QA PROCESS, DATA INTERPRETATION, QA REPORTS PREPARATION, CALIBRATION, MEASURING INSTRUMENTS, LAB QA, IATF, APQP, PPAP etc Required Candidate profile DIP/BE 3+yrs exp into QA with Tier1/2 AUTOMOTIVE unit handling key QA Tasks Strong exposure in INJECTION MOLDING, BLOW MOLDING & EXTRUSION PROCESSES must Work @ ORAGADAM Strong Auto Unit exp must Perks and benefits Excellent Perks. Call Rajeswari@ 96770 76683 now
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
3.0 - 8.0 years
5 - 8 Lacs
Bharuch
Work from Office
Must have Excellent Understanding of Organizational Structure, Accurately record & report data, Completes documentation relating to material analysis & enters data into database/software system Required Candidate profile Extensive knowledge of QC Tools required, Knowledge of IATF/IMS.
Posted 3 months ago
4.0 - 9.0 years
3 - 6 Lacs
Bharuch
Work from Office
Must have Excellent Understanding of Organizational Structure, Accurately record & report data, Completes documentation relating to material analysis & enters data into database/software system Required Candidate profile Extensive knowledge of QC Tools required, Knowledge of IATF/IMS.
Posted 3 months ago
20.0 - 30.0 years
10 - 15 Lacs
Bharuch
Work from Office
Supervise & control the Testing in Lab to analyze specifications of materials as per Customer standards.Coordinate with Stores about Raw Materil & Import RM sampling.Ensuring testing of Raw Matrial, In-proces & per sampling plan for NTCF & NFY plan. Required Candidate profile Testing of all incoming chemicals & chips & in process testing. Approve or reject materials based on the test results.Highlighting the property deviation.Ensuring re-test in case of abnormal test res
Posted 3 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
- 5 years
1 - 4 Lacs
Paonta Sahib, Chandigarh, Panchkula
Work from Office
Role & responsibilities We are seeking a diligent and experienced QA & QC & production. The successful candidate will Ensure that our products meet specified quality standards. This role involves managing both Quality Assurance ( QA ) and Quality Control (QC) processes, conducting inspections, and implementing improvements to maintain and enhance product quality. Expanding role in building a team of QA/QC executives. Salary Range: 15,000 to 25,000 (negotiable based on experience & skills) Experience: Minimum 2 years in QA/QC department of Tablet & Capsule or pharma manufacturing unit Preferred candidate profile Quality control analyst Responsible for testing and analyzing pharmaceutical prod...
Posted 5 months ago
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