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2.0 - 7.0 years
1 - 5 Lacs
jadcherla
Work from Office
Responsible for In-Process Quality Assurance (IPQA) activities in Injectable manufacturing (SVP/LVP/Oncology) . Monitoring of aseptic area operations including compounding, filtration, filling, sealing, and lyophilization. Ensure compliance with cGMP, GLP, and regulatory guidelines (USFDA, EU-GMP, WHO). Line clearance verification for manufacturing and packing operations . Review and approval of BMR/BPR , logbooks, and manufacturing documents. In-process checks during vial washing, sterilization, depyrogenation tunnel, filling, and autoclave operations . Monitoring of environmental conditions and coordination with Microbiology team. Handling of deviations, OOS/OOT , change controls, and CAPA...
Posted 15 hours ago
3.0 - 8.0 years
5 - 8 Lacs
pune
Work from Office
Role & responsibilities Ensure cGMP compliance during manufacturing operations Perform line clearance and in-process checks Review BMR/BPR , logbooks, and manufacturing documents Monitor critical process parameters (CPPs) on shop floor Initiate, investigate, and close deviations Prepare and follow up CAPA Support change control and risk assessments Ensure compliance with SOPs, GDP, and data integrity (ALCOA+) Participate in internal audits and regulatory inspections Coordinate with Production, QC, and Engineering teams Preferred candidate profile Strong knowledge of cGMP / GMP guidelines Exposure to USFDA / EU-GMP / WHO regulations Experience in BMR/BPR review & issuance Deviation, CAPA, cha...
Posted 16 hours ago
1.0 - 4.0 years
3 - 6 Lacs
surat
Work from Office
Job Title : Officer - Documentation Functional Area : QA Key Accountabilities Technical and QMS Documentation: Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same. Handling of Deviation, Non-Conformance, Change controls and CAPA. Handling of Post market surveillance Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission. Preparation of Technical files in co-ordination with R&D Team. Preparation of Design file as per ISO 13485:2016, MDR and USFDA. Handling of Adverse event reporting to EU and other regulatory body. Familiar to handle Eudamed, Maude and other databases Valida...
Posted 16 hours ago
7.0 - 12.0 years
35 - 50 Lacs
baddi
Work from Office
0 Responsibilities: To carry out the following routine checks in the laboratory on daily basis: Responsibility for investigation report writing and closure of deviation, OOS and OOT. Qualification of working standards. Glassware verification & labelling. Routine calibration and verification of all instruments. Logbooks verification. To ensure that the documentation done is online and error free. To ensure the correctness of the document before submitting it for the review of Group Leader/AQA reviewer. Column stock, inventory, indent, requirement and routine usage verification. Reference/Working standard and impurities verification. Area upkeep and maintenance. Calibration schedule/document/l...
Posted 19 hours ago
10.0 - 12.0 years
10 - 14 Lacs
hyderabad
Work from Office
Role & responsibilities Deputy Manager - IPQA DS Experience - 10-12yrs 1. Cell bank management 2. Issuance of line clearance 3. Upstream and Downstream batch record review 4. Routine IPQA activities 5. Hands on experience on digital systems such as Trackwise/ Veeva/ SAP/ LMS/ DMS/ E-Val etc. 6. Deviation, OOS, OOT investigation review and approval 7. Change control initiation, review, approval 8. CAPA initiation, review and effectiveness verification 9. Exposure to regulatory audits 10. Risk assessment review and approval 11. Process and cleaning validation 12. APQR preparation and review 13. Periodic Trending of QMS elements 14. Review and approval of environmental monitoring trends 15. Rev...
Posted 19 hours ago
2.0 - 6.0 years
4 - 8 Lacs
bavla
Work from Office
Dishman Carbogen Amcis Ltd is looking for Executive API QC to join our team Collaborate with cross-functional teams to achieve strategic outcomes. Apply subject expertise to support operations, planning, and decision-making. Utilize tools, analytics, or platforms relevant to the job domain. Ensure compliance with policies while improving efficiency and outcomes.
Posted 1 day ago
0.0 - 7.0 years
2 - 7 Lacs
navi mumbai
Work from Office
1-Understanding of regulatory requirements 2-Must Have Knowledge in regulation of Class I, II and III medical devices 3-Exp in regulatory affairs within the medical device industry. Interested candidate can directly apply on recruit@shalya.in
Posted 1 day ago
2.0 - 3.0 years
2 - 2 Lacs
baddi
Work from Office
Coordinate with production teams to resolve quality issues in real time, Ensure compliance with GMP, ISO, or other applicable quality standards Verify raw materials, semi-finished, and finished products as per quality parameters.
Posted 1 day ago
2.0 - 7.0 years
3 - 8 Lacs
hyderabad
Work from Office
PRODUCTION: (Injectables) Designation : Officer/Senior Officer/Executive/Senior Executive/AM/DM Qualification : Diploma / B. Sc / M. Pharmacy / B. Pharmacy / M.Sc Experience : 2-12 Years Role : Filling/Autoclave/Compounding/Lyo/PFS Quality Control: (Injectables) Designation : Senior Executive/Assistant Manager Qualification : B. Pharm / M.Sc. Experience : 2-9 Years Role : Investigations - QMS Microbiology: (Injectables) Designation : Executive/Senior Executive/Assistant Manager Qualification : M.Sc / B.Tech (Microbiology/Biotechnology) Experience : 2-9 Years Role : Testing /Environmental Monitoring/QMS Engineering: (Injectables) Designation : Officer/Sr.Officer/Executive/Sr.Executive/DM/Mana...
Posted 1 day ago
3.0 - 8.0 years
2 - 7 Lacs
bengaluru
Work from Office
Walk In Interview on 20th Dec 25 For IPQArole . Below is the documents to be carried along with you: 1. One passport Size photo 2. All the academic certificates 3.Last 3 months Payslip. Note: Freshers are not applicable, only experienced candidates are required. The person should have good communication skills. Preferred only Male Candidates. IPQA Incharge :-- Experience : 6 to 10 years. Designation : Executive/Sr. Executive Qualification : B. Pharm/M. Pharm 1) Draft review of MFR, MBMR, MPR and BPR 2) Review of executed batch records and batch release 3) Review for Batch release 4) Deviation associated with Operational quality 5) Exposure in Regulatory in order to schedule M and Other regul...
Posted 2 days ago
3.0 - 6.0 years
4 - 6 Lacs
himachal pradesh, punjab
Work from Office
quality inspector required at baddi, himachal Qualification- any chemical or pharma Exp- min 3 yrs(in OSD company) salary- upto 35k Skills- testing , controlling, work check as assigned SOP's Wtsapp me resume at 8295842337- Mr. Bansal Required Candidate profile Perform in-process & finished product inspections, ensure SOP/GMP compliance, monitor quality parameters, record results, control deviations, support audits, and maintain accurate QC documentation.
Posted 2 days ago
6.0 - 10.0 years
5 - 15 Lacs
bengaluru
Work from Office
Walk In Interview on 20th Dec 25 For QA role . Below is the documents to be carried along with you: 1. One passport Size photo 2. All the academic certificates 3.Last 3 months Payslip. Note: Freshers are not applicable, only experienced candidates are required. The person should have good communication skills. Preferred only Male Candidates. Job Responsibilities for QA Designation Sr. Executive Experience should have 6 to 10 years. Qualification : B. Pharm/M. Pharm 1) Subject matter expert in Quality Management system such as change control, Deviation, Market complaint, CAPA and Risk Management etc. 2) Handling regulatory compliance 3) Batch release 4) Audit Management 5) Exposure in Regulat...
Posted 2 days ago
4.0 - 7.0 years
6 - 10 Lacs
lucknow
Work from Office
Collaborate with the HR systems strengthening team and Government of Uttar Pradesh Stakeholders to support eHRMS implementation. Assist in HR recruitments and project documentation. Develop and implement effective HR strategies to strengthen organizational systems. Work closely with cross-functional teams to achieve organizational goals. Analyze data and provide insights to inform business decisions. Ensure compliance with regulatory requirements and industry standards. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via t...
Posted 2 days ago
8.0 - 13.0 years
12 - 16 Lacs
vapi, ahmedabad, mumbai (all areas)
Work from Office
shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc Label artwork review and management Required Candidate profile Assisting HOD in customer complaint analysis and preparation of customer complaint report. Investigation of incidents, deviations, OOS and ensure corrective actions in place.
Posted 3 days ago
5.0 - 10.0 years
7 - 12 Lacs
lucknow
Work from Office
Roles and Responsibilities Manage contracts from initiation to closure, ensuring compliance with company policies and regulatory requirements. Conduct BPR reviews, audits, and quality checks to ensure adherence to IPQA standards. Develop and maintain documentation related to contracts, including change controls, deviations, and non-conformities. Collaborate with cross-functional teams for effective project management, planning, reporting, and training. Ensure timely completion of tasks by monitoring progress against schedules and identifying potential roadblocks.
Posted 3 days ago
2.0 - 7.0 years
4 - 8 Lacs
jammu
Work from Office
Key responsibilities: Executes online Batch Packing Records, online in process as per the parameters mentioned in the BPR, logbook, documents and other formats. take line clearance of area / machine as per respective SOPs. maintain / fill all area / machine related documents like Sequential, area cleaning, daily cleaning log books and other formats of machine & area as per SOP. verify and receiving of dispensed packing material. indent / receive / handle / verification / uses & destruction of stereo as per respective SOP. verify the Leak test of blister / strip as per frequency. If result not satisfactory, rectify the problems. maintain, handle / storage / labelling of machine spares /change...
Posted 5 days ago
0.0 - 5.0 years
2 - 3 Lacs
navi mumbai
Work from Office
QA documentation, specifications, & analysis protocols, ensuring cGMP compliance through QA rounds, line clearance, in-process monitoring validation oversight, final product inspection, dispatch coordination & reserve sample management.
Posted 5 days ago
4.0 - 6.0 years
4 - 6 Lacs
kadi, ahmedabad
Work from Office
Role & responsibilities In-Process Quality Assurance (IPQA): Documentation & Compliance: Regulatory & Audit Support: Training & Process Awareness: Preferred candidate profile Education: B.Sc. / M.Sc. in Chemistry, Biochemistry, or Pharmacy.
Posted 5 days ago
0.0 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 6 days ago
4.0 - 7.0 years
3 - 5 Lacs
nashik
Work from Office
Sr. Officer - QALL: Work Location - Baddi, Baroda & Navsari Ensure GMP/GLP compliance at Contract Manufacturing sitesand third party sites and provide registration documents and required support for registration from site. Ensure availability of current valid masterdocuments like raw material /packing material /finished product specificationsbatch manufacturing record /batch packing record at site and retrieval ofobsolete documents. To check and find non compliances at Contract Manufacturing /Third Party location and ensure corrective and preventive action. To execute, ensure and monitor processvalidation / Technology Transfer activities, Unit Operation, QMS Compliance atsite and arrange for...
Posted 6 days ago
5.0 - 6.0 years
1 - 6 Lacs
india, sikkim
Work from Office
Division Department Sub Department 1 Job Purpose Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets Key Accountabilities (1/6) Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target Utilise shift resources optimally to get desired production output Regulate usage of consumables in the production process at optimum level to save cost Key Accountabilities (2/6) Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement Review and monitor critical in-process parameters like NFD, camera ...
Posted 6 days ago
3.0 - 8.0 years
4 - 5 Lacs
bengaluru
Work from Office
EXL Services.com ( I ) Pvt. Ltd. is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel a...
Posted 1 week ago
3.0 - 6.0 years
5 - 8 Lacs
ahmedabad
Work from Office
Key Responsibilities: Environment monitoring Aseptic area behaviour and monitoring Handling of Instrument i.e NVPC and MAS. Personnel monitoring Trend analysis and reporting Sample handling
Posted 1 week ago
3.0 - 6.0 years
5 - 8 Lacs
ahmedabad
Work from Office
Description: To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitoring, documentation review, sampling, and area/machine clearances, thereby supporting the production of high-quality injectable pharmaceutical products Essential Functions: To ensure cGMP and compliance review in the manufacturing shop floor and packing areas. To supervision of dispensing activity of manufacturing shop floor and packing areas. To Issuance of Bottle label, Ouster and Medication guide for commercial batch. Rsponsible for providing machine and area clearance. To conduct Sampling of ...
Posted 1 week ago
4.0 - 7.0 years
4 - 7 Lacs
hyderabad
Work from Office
Role & responsibilities 1. Perform and monitor In-process Quality Assurance activities during the manufacturing process. 2. Responsible to perform line clearance activities in different stages of manufacturing and Monitoring of cleanroom behavior, aseptic activities. 3. Responsible to verify the In-process samples for quality testing and ensure the test results of products at various stages of manufacturing. 4. Review and verify documentation related to manufacturing processes i.e., BMR, BPR and GMP documents, ensuring accuracy and completeness. 5. Regularly inspect and assess manufacturing operations to ensure compliance with quality standards and procedures. 6. Responsible to Preparation &...
Posted 1 week ago
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