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2.0 - 5.0 years
4 - 7 Lacs
pune, jejuri
Work from Office
1. Monitor raw material dispensing activity. 2. Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations. 3. Conduct validation sampling as per approved validation protocols. 4. Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance. 5. Perform ERP-related transactions of IPQA. 6. Check BSR (Batch Summary Record) and Shipper inspection as per SOP. 7. Manage issuance, review, and reconciliation of formats across all departments. 8. Conduct IPQA rounds and share observations with concerned HODs for corrective action and compliance. 9. Ensure cleaning, sanitation, and hygiene in all departments to maint...
Posted 1 month ago
0.0 - 3.0 years
2 - 4 Lacs
mangaluru
Work from Office
Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review
Posted 1 month ago
10.0 - 17.0 years
9 - 15 Lacs
chennai
Work from Office
QA Manager OSD/Liquid formulation background.Must have experience in BMR, batch release,validations,qualifications,SOPs,GMP,audits,QMS(Deviation,OOS, OOT, CAPA), tech transfer. Analytical exposure is an added advantage Resume to hrd@stedmanpharma.com
Posted 1 month ago
0.0 - 3.0 years
2 - 4 Lacs
mangaluru
Work from Office
Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review
Posted 1 month ago
2.0 - 6.0 years
0 - 0 Lacs
ankleshwar, gujarat
On-site
As a Senior QA Officer, your role will involve various responsibilities to ensure quality assurance within the API pharma industry. You will be tasked with issuing Batch Manufacturing Records, equipment cleaning records, logbooks, and analytical reports for raw materials, finished products, and packing materials. Additionally, you will assist in the preparation of SOPs for different departments and conduct plant rounds to verify documents according to cGMP and GLP norms. Line clearance activities for manufacturing and packaging, issuing deviation forms, change control forms, and handling customer complaints will also be part of your duties. You will review and verify analytical and Batch Man...
Posted 1 month ago
5.0 - 10.0 years
8 - 9 Lacs
ahmedabad
Work from Office
We are seeking a dedicated Senior Validation position at a reputed pharmaceutical organization based in Ahmedabad. Experience : 5+ Years Qualification : B.Pharma Role & responsibilities Thermal mapping for mixing/holding vessels, steam sterilizers (autoclaves), terminal sterilizers, depyrogenation tunnels, lyophilizers, filling machines, cold rooms, and cleanroom areas, Media fill Isolator and HVAC system ,Process validation and equipment Utility : compressed air, nitrogen, and steam quality testing. Change control, CAPA, and process understanding. Protocol, validation report, and SOP preparation , Cleaning validation. Interested candidate with the required qualification and experience are e...
Posted 1 month ago
6.0 - 10.0 years
5 - 10 Lacs
hyderabad
Work from Office
Job Title: Assistant Manager In-Process Quality Assurance (IPQA) Department: Quality Assurance Location: Hyderabad, Jeedimetla Reporting To: Manager Quality Assurance / Head Quality Job Purpose: To ensure that all in-process operations are monitored and compliant with applicable cGMP, SOPs, and regulatory requirements. The IPQA Assistant Manager is responsible for in-line quality checks, deviation control, batch record review, and timely escalation of non-conformities during manufacturing and packaging processes. 1. In-Process Quality Monitoring Supervise and execute IPQA activities during manufacturing and packaging. Perform real-time line clearance, process checks, and verification. Ensure...
Posted 1 month ago
10.0 - 15.0 years
0 Lacs
karnataka
On-site
As a Manager Quality Assurance at Syngene International Ltd., you will be responsible for ensuring compliance with all national and international regulatory agency requirements related to API manufacturing. Your role will involve evaluating and approving vendors/subcontractors, reviewing and approving various reports such as SOP, analytical method validation, and calibration reports, and coordinating review meetings to maintain the effectiveness of the quality system. You will be expected to have a strong understanding of regulatory requirements from agencies such as ICH, USFDA, WHO Geneva, PMDA Japan, and others. Additionally, you will play a key role in the approval of protocols and report...
Posted 1 month ago
8.0 - 13.0 years
0 - 1 Lacs
hosur
Work from Office
Job Title: Manager Quality Assurance (QA) Company: Global Calcium Pvt. Ltd. Location: Unit III – Hosur, Tamil Nadu Experience: 10+ years Qualification: B.Pharm / M.Pharm / M.Sc or equivalent Job Description: We are looking for an experienced Manager – QA to lead our Quality Assurance team at Global Calcium Pvt. Ltd., Unit III (Hosur). Key Responsibilities: Lead Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Manage validation and qualification of equipment, utilities, and processes. Ensure audit readiness and compliance with regulatory agencies (USFDA, EU, WHO, MHRA). Review and approve SOPs, protocols, and reports related to validation and qua...
Posted 1 month ago
14.0 - 16.0 years
13 - 17 Lacs
bengaluru
Work from Office
1. Quality Systems & Documentation: Develop, implement, and maintain GMP-compliant QMS. Oversee change control, deviations, CAPA, incident management, risk assessment, and market complaints. Ensure GDP compliance in all QA documentation, including SOPs, batch records, specifications, and MOAs. Prepare and revise SOPs, distribute and retrieve old versions, and manage documentation control. Handle QMS activities like return goods, non-conformities, and investigation reports (5-Why, 6M method). 2. Validation & Qualification: Review and approve URS, IQ, DQ, OQ, and PQ protocols and reports. Manage process validation, cleaning validation, equipment qualification, and facility validation. Conduct ...
Posted 2 months ago
4.0 - 9.0 years
3 - 6 Lacs
visakhapatnam
Work from Office
We are looking for a meticulous Sr. Executive - Production to spearhead production activities and ensure adherence to stringent quality standards at Synnat Pharma Private Limited. As Sr. Executive - Production, you will play a pivotal role in managing batch manufacturing records, equipment compatibility, and various validation protocols, including process, cleaning, blending, drying, and micronization. The ideal candidate will be adept at preparing master formula records, quality equivalence reports, and standard operating procedures, while also taking the initiative for change controls and performance qualifications. This role demands a strong understanding of QMS activities, internal and e...
Posted 2 months ago
3.0 - 5.0 years
0 - 0 Lacs
hyderabad
Work from Office
Dear All, Greetings from Aizant Drug Research Solutions!! We are looking for a motivated professional with strong expertise in Cleaning Validation (QA Formulations) to join our Quality Assurance team. The ideal candidate should have hands-on experience in planning, executing, and documenting cleaning validation activities as per regulatory requirements. Experience: 3-5 Years Location: Hyderabad(Dulapally) Department: Quality Assurance(Formulations) Key Responsibilities: -Preparation and review of Cleaning Validation protocols, reports, and risk assessments. -Execution and monitoring of Cleaning Validation studies as per cGMP guidelines. -Identification of worst-case products and development ...
Posted 2 months ago
5.0 - 9.0 years
0 Lacs
hyderabad, telangana
On-site
You should possess a B. Pharmacy/M. Pharmacy (Pharmaceutical Analysis and Quality Assurance) or M. Sc. in Chemistry or equivalent with 5 to 8 years of experience in formulation pharmaceutical industries in the quality control department. In this role, you will be responsible for handling day-to-day activities related to sampling, testing, and release of active ingredients, inactive ingredients, packaging materials, in-process and finished products, stability samples. Your primary responsibilities include ensuring that all activities within the quality control section meet current applicable cGMP guidelines and regulatory expectations. You will be accountable for ensuring timely sampling, ana...
Posted 2 months ago
7.0 - 12.0 years
5 - 8 Lacs
visakhapatnam
Work from Office
We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Spe...
Posted 2 months ago
5.0 - 8.0 years
2 - 6 Lacs
kadi
Work from Office
Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5-8 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...
Posted 2 months ago
5.0 - 8.0 years
2 - 6 Lacs
kadi
Work from Office
Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/...
Posted 2 months ago
8.0 - 10.0 years
4 - 8 Lacs
kathua
Work from Office
Senior Executive QA 1 Post based in Kathua, Jammu & Kashmir The ideal candidate brings 8-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) S...
Posted 2 months ago
5.0 - 8.0 years
2 - 6 Lacs
mehsana, kadi
Work from Office
Sr. Executive / Executive based in Kadi, Mehsana District, Gujarat. The ideal candidate brings 5 to 8 years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Le...
Posted 2 months ago
2.0 - 4.0 years
0 Lacs
bengaluru, karnataka, india
On-site
About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Method verification/validation of compendia/pharmacopeial updations, Method ve...
Posted 2 months ago
3.0 - 4.0 years
3 - 3 Lacs
amritsar
Work from Office
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
Posted 2 months ago
3.0 - 7.0 years
0 Lacs
gujarat
On-site
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...
Posted 2 months ago
3.0 - 7.0 years
14 - 18 Lacs
mumbai
Work from Office
Treasury Treasury at Deutsche Bank is responsible for sourcing, managing, and optimizing Deutsche Bank's financial resources and providing high-quality steering to the Bank on financial resource deployment. Treasury's fiduciary mandate encompasses the Bank's funding pools, asset and liability management (ALM), liquidity reserves management, and supporting businesses in delivering their strategic targets at the global and local levels. Further, Treasury manages all financial resource optimization to implement the group's strategic objective and maximize long-term return on average tangible shareholders' equity (RoTE). The current role is part of the Treasury Office in Mumbai. The position req...
Posted 2 months ago
2.0 - 3.0 years
3 - 7 Lacs
ahmedabad
Work from Office
Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies ...
Posted 2 months ago
2.0 - 6.0 years
3 - 7 Lacs
ahmedabad
Work from Office
Purpose of Job 1. Preparation and Review of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Having basic knowledge on Microsoft Word and Microsoft Excell 2. Have knowledge of Minitab software for statstical evaluation of data. Roles and Responsibilites 1. Preparation and review of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern depa...
Posted 2 months ago
2.0 - 7.0 years
4 - 8 Lacs
ahmedabad
Work from Office
Purpose of Job 1. Preparation of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Utilization of Microsoft Word and Microsoft Excell 2. Using of Minitab software for statstical evaluation. Roles and Responsibilites 1. Preparation of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Quali...
Posted 2 months ago
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