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19.0 - 24.0 years
18 - 30 Lacs
pune
Work from Office
Roles & Responsibilities: Microbiological Risk Management: Identify, assess, and control microbiological risks in raw materials, production processes, utilities, and finished products. Develop and implement effective control strategies. Laboratory Operations Management: Lead and oversee all microbiology laboratory activities including: Routine testing of raw materials, in-process, and finished products. Method validation/verification and equipment qualification. Cleaning validation and environmental monitoring (EMPQ). Microbial identification and trending of environmental monitoring results. Technical Problem Solving: Investigate and resolve laboratory technical issues, out-of-specification ...
Posted 2 days ago
8.0 - 10.0 years
9 - 10 Lacs
vapi
Work from Office
Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assuran...
Posted 3 days ago
2.0 - 4.0 years
2 - 4 Lacs
kadi, ahmedabad
Work from Office
Role & responsibilities Manufacturing of Lyophilized Drug Product Aseptic Blending & Filling Injectable Filling Lyophilization BMR Preparation cGMP Practices, Media Preparation, Vial Washing and De-pyrogenation, Validation, Labeling & Packaging, Documentation Preferred candidate profile Aseptic handling Sound knowledge of QMS Sound knowledge of cGMP, GDP
Posted 1 week ago
1.0 - 6.0 years
4 - 7 Lacs
vadodara, waghodia
Work from Office
The ideal candidate brings 1-6 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) Lead microbiology practices including EM, MLT, sterility assur...
Posted 1 week ago
1.0 - 6.0 years
4 - 7 Lacs
vadodara, waghodia
Work from Office
The ideal candidate brings 1-6 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) Lead microbiology practices including EM, MLT, sterility assur...
Posted 2 weeks ago
5.0 - 6.0 years
4 - 5 Lacs
kadi, ahmedabad
Work from Office
Role & responsibilities Cell Culture & Production Support: Perform aseptic handling and maintenance of cell cultures (e.g., Vero, BHK or other cell lines) in adherent and/or suspension formats. Prepare and sterilize culture media, buffers, and reagents as per batch requirements and SOPs. Monitor and record cell growth parameters, viability, and morphology. Scale-up cell cultures for downstream processing or viral seed production. Facility & Environmental Monitoring: Conduct routine facility checks including temperature, humidity, pressure differentials, and cleanroom conditions. Coordinate and ensure compliance with environmental monitoring schedules (viable/non-viable particles, surface, an...
Posted 3 weeks ago
10.0 - 15.0 years
15 - 18 Lacs
nalagarh
Work from Office
Role & responsibilities - Ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at the microbiology laboratory. - Participate in the sterile quality management review periodically - Ensure the microbial monitoring program in the site is adequate Environmental Monitoring (EM) Personnel Monitoring Media Fill Simulations (Process Simulations) - Periodic review and routine check of classified areas in microbiology lab areas - Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product - Participate in the...
Posted 3 weeks ago
1.0 - 6.0 years
4 - 7 Lacs
vadodara, waghodia
Work from Office
The ideal candidate brings 1-6 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) Lead microbiology practices including EM, MLT, sterility assur...
Posted 3 weeks ago
18.0 - 25.0 years
30 - 35 Lacs
nalagarh
Work from Office
Role & responsibilities - Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site - Conduct sterile quality management review periodically - Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas - Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification - Ensuring SOP adherence to clean room facility / utilities/ equipment / Personnel qualifications whichever has a potential to impact the Sterility of the product. - Review validation / protocol studies which has potential to d...
Posted 3 weeks ago
2.0 - 4.0 years
2 - 4 Lacs
kadi, ahmedabad
Work from Office
Role & responsibilities Manufacturing of Lyophilized Drug Product Aseptic Blending & Filling Injectable Filling Lyophilization BMR Preparation cGMP Practices, Media Preparation, Vial Washing and De-pyrogenation, Validation, Labeling & Packaging, Documentation Preferred candidate profile Aseptic handling Sound knowledge of QMS Sound knowledge of cGMP, GDP
Posted 1 month ago
5.0 - 10.0 years
5 - 9 Lacs
amritsar
Work from Office
Role & responsibilities : Equipment Qualification DPI liquid Injection Cleaning Validation Ampoule ,Vial Washing Media Fill Leak Test Line Clearance In Process Validation( Related to sampling ) Dental cartridge BMR/BPR
Posted 1 month ago
2.0 - 5.0 years
3 - 4 Lacs
navi mumbai
Work from Office
Role & responsibilities 1. Experience in Batch Preparation. 2. Batch Filling. 3. Aseptic Maintenance. 4. Media FIll. 5. Validation. Preferred candidate profile From sterile formation injectable plant. Perks and benefits 1. Pickup and Drop Facility 2. Canteen Facility
Posted 1 month ago
2.0 - 6.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a responsible team member in the pharmaceutical manufacturing process, your role involves the following key responsibilities: - Conduct line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. - Perform process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling according to protocol/SOP. - Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). - Perform in-process tests at different stages as per batch documents/SOP. - Review environmental monitoring and water trends. - Review different types of calibration certifica...
Posted 1 month ago
10.0 - 15.0 years
14 - 16 Lacs
hyderabad
Work from Office
Role & responsibilities To perform operation and changeover of the equipments like Vial Filling & Stoppering Machine, Vial Cap Sealing Machine, Vial Washing Machine, Sterilizing and Depyrogenation tunnel, Lyophilizer, Autoclave, Pasteurizer, Incubator, Fogger and Filter integrity tester. Actively involve in fill finish operation and media fills. Preparation and review of general and equipment operation SOP’s. Involve in preparation and reviewing of BMR, MFR & Validation protocol etc. Compilation of all critical process attribute to analyze yield variation and investigation of low yield batches or OOS routed through change control or deviation. To get involve in external and internal regulato...
Posted 1 month ago
1.0 - 6.0 years
4 - 7 Lacs
vadodara, waghodia
Work from Office
The ideal candidate brings 1-7 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) Lead microbiology practices including EM, MLT, sterility assur...
Posted 2 months ago
5.0 - 10.0 years
5 - 15 Lacs
dahej, indore, daman & diu
Work from Office
1). Department:- Engineering Services (OSD & API) Job Location:- Indore, Madhya Pradesh Position:- Operator/ Technical Associate/ Officer/ Sr. Officer Qualification:- B.E./ B.Tech (Electrical/ Mechanical/ ECE)- (For Officer/ Sr. Officer ) ITI/ Diploma (Electrical/ Mechanical)/ Any Graduate (For Operator/ Technical Associate) Experience:- 2 to 8 Years of experience in HVAC/ Plant Maintenance/ Utility/ Water System/ Calibration 2). Department:- Quality Control (OSD) Job Location:- Daman/ Indore/ Sarigam Position:- Officer/ Sr. Officer Qualification: - M.Sc. (Chemistry) / B.Pharm/ M. Pharm Experience:- 3-6 years of experience in Finished Products/ Raw Material/ Stability/ Packing material / Ana...
Posted 2 months ago
5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
The role involves handling document issuance, distribution, and retrieval, including verification of various documents such as Batch Manufacturing records, Protocols, layouts, specifications, etc. Issuing approved Standard Formats and Logbooks to User Departments, as well as managing line-clearance checklists, interventions checklist, and BMR/BPR pages. Additionally, handling proposed changes per the change control procedure, assessing associated risks/impacts, and ensuring the implementation of action plans. Conducting investigations using root cause analysis tools, performing additional studies, and deriving appropriate CAPA. Managing recommended CAPA and evaluating the implementation of r...
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
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for conducting line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. Additionally, you will perform environment monitoring activities and ensure compliance with cGMP at the shop floor. Your role will involve process validation, cleaning validation/verification, hold time study, media fill, routine batch sampling, and in-process testing at different stages according to batch documents and SOPs. You will review executed BMRs, BPRs, environment monitoring data, water trends, printouts (CIP, SIP, autoclave, filter integrity), and different types of planner and calibration certif...
Posted 2 months ago
3.0 - 6.0 years
2 - 4 Lacs
amritsar
Work from Office
KWALITY PHARMACEUTICALS LTD. 6 , MILE STONE, VILL. NAG KALAN, TH MAJITHA ROAD, AMRITSAR , PUNJAB 143601 (INDIA) About Our Organisation : Kwality Pharmaceuticals Ltd. is a manufacturer of finished pharmaceutical formulations in a dosage form. The company was incorporated on May 4 1983, and is ever progressing in Domestic and International markets. Kwality Pharma was Incorporated on May 4th 1983 by Mr. Ramesh Arora ( Founder ) of the company . Our company is based on its commitment to high quality and timely supplies. Kwality Pharmaceuticals Ltd are leading manufacturer & exporters of pharmaceutical formulations in Liquid Orals, Powder for Oral Suspension, Tablets, Capsules, Sterile Powder for...
Posted 2 months ago
1.0 - 4.0 years
1 - 3 Lacs
udaipur
Work from Office
Preferred candidate profile 1. Expose to injection facility 2. Qualification of equipment 3. Process Validation 4. Media Fill 5. IPQA activity 6. QMS & other documentation
Posted 2 months ago
3.0 - 8.0 years
2 - 5 Lacs
Ahmedabad
Work from Office
Role & responsibilities 1.1 To perform the media preparation, sterilization, disposal and record maintenance. 1.2 To transfer & Maintenance of all microbial pure cultures & record maintenance. 1.3 To perform a growth promotion test for microbiological media and observation. 1.4 To prepare the disinfectant solutions. 1.5 To perform microbial monitoring of classified areas of QC and production areas. 1.6 To perform the microbial analysis as per the method of analysis. 1.7 To operate and maintain the equipment/instruments as per respective SOP. 1.8 To monitoring and recording of differential pressure, temperature and humidity of the microbiology laboratory. 1.9 To receipt and handling of microb...
Posted 3 months ago
3.0 - 8.0 years
4 - 7 Lacs
Nagpur
Work from Office
Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperat...
Posted 4 months ago
2.0 - 7.0 years
3 - 8 Lacs
Ahmedabad
Work from Office
Walk-in @ GOA We are hiring multiple positions for our manufacturing facility at AHMEDABAD as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / Market Compliance / IPQA - (injectables) (Officer / Senior Officer / Executive/Senior Executi...
Posted 4 months ago
2.0 - 7.0 years
4 - 9 Lacs
Hyderabad
Work from Office
Dear Aspirant , Greetings From Eugia Pharma Specialties Limited (Aurobindo Group)!!!! We glad to inform you all that we planned Walk In Interviews for below vacancies in our Manufacturing unit. Department : Quality Assurance (IPQA) No. of Vacancies : 30 Education Qualification : B. Pharmacy / M Pharmacy Experience : 2-5 Years Designation : Executive Required Skills : Aseptic Area Monitoring / Environmental Monitoring / Aseptic behavior / Media Fill / Gowning Practices / Sterility Assurance/ In Process checks in Injectable Work Location : Eugia Unit -3, Pashamylaram Walk In Details: Date : 29.06.2025 Time : 09 AM - 02 PM Venue : Aurobindo Pharma Limited - Unit - 3 Sy. No. 313, Bachupally, Hyd...
Posted 4 months ago
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