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2.0 - 7.0 years
4 - 7 Lacs
ahmedabad
Work from Office
protocol & reports of equipment / utility qualification Responsible for execution of equipment / utility qualification. process validation cleaning validation Annual Product review Validation Master Plan. Computer System Validation/ PLC validation Perks and benefits Food & Transportation, Bonus & Gratuity Separately
Posted 18 hours ago
5.0 - 8.0 years
3 - 6 Lacs
kalol, mehsana, ahmedabad
Work from Office
Role & responsibilities 1 Preparation of standard operating procedure. 2 Preparation of quality documents. 3 Initiate / review of change control system. 4 Initiate / review of deviation. 5 Initiate / review of CAPA. 6 To control, issue, retrieve, retention and disposal of GMP documents as per standard procedure. 7 Review of MFR/BMR/BPR/ECR. 8 Review of validation protocols and report. 9 To participate in investigation of OOS for RM/intermediate/FP. 10 To participate in market complaint handling. 11 Review of vendor qualification documents. 12 Review of executed manufacturing and analytical records. 13 Preparation of annual product quality review. 14 To take plant round and ensure compliance ...
Posted 1 day ago
5.0 - 10.0 years
5 - 10 Lacs
ahmedabad
Work from Office
Roles and Responsibilities Conduct Process Validation, Equipment Qualification, and Cleaning Validation activities according to SOPs. Prepare documents for Capa, MACO, OSD, and SOP preparation. Ensure compliance with regulatory requirements through quality control measures. Collaborate with cross-functional teams to resolve quality issues. Maintain accurate records of all quality-related activities. Desired Candidate Profile 5-10 years of experience in Quality Assurance (QA) or related field. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of pharmaceutical industry regulations and standards. Proficiency in equipment qualification, cle...
Posted 3 days ago
1.0 - 6.0 years
4 - 9 Lacs
ahmedabad
Work from Office
Responsibilities: * Collaborate with cross-functional teams on equipment qualifications & CSV. * Ensure compliance with 21 CFR Part 11, IQ/OQ/PQ procedures. * Manage validation projects from planning to closure. Flexi working Work from home Over time allowance Travel allowance Food allowance Health insurance Annual bonus Retention bonus Job/soft skill training
Posted 4 days ago
5.0 - 7.0 years
6 - 8 Lacs
kadi, ahmedabad
Work from Office
Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available for daily commute) Note: Immediate joiners will be preferred first
Posted 6 days ago
5.0 - 9.0 years
2 - 6 Lacs
baddi
Work from Office
1. To prepare annual equipment qualification planner with respect to validationmaster plan. 2. To prepare HVAC / compressed air / effectiveness of cleaning validation planner. 3. Preparation of protocols for qualifications of newly procured equipments and ofequipments transferred from other location. 4. Preparation of protocols for re-qualifications of HVAC system. 5. Preparation and execution of re-qualification protocols and reports as per schedule ofvalidation master plan and as on when required. 6. Toperform cleaning validation cleaning verification. 7. Preparationreview of cleaning assessment report. 8. Preparation review of process validation protocols and reports. 9. Preparation revie...
Posted 1 week 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 2 weeks ago
3.0 - 7.0 years
2 - 5 Lacs
bengaluru
Work from Office
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 This role will develop experimental approaches and will be responsible for ana...
Posted 2 weeks ago
5.0 - 10.0 years
5 - 15 Lacs
mumbai suburban
Work from Office
POSITION DESCRIPTION Position Title Asset Management specialist - Support India (Research/Documentation/Project support) Reports to Global Supply Chain Plant & Equipment Director Location/Project Position Summary The Asset Management Specialist – Data Management will play a critical role in supporting the Asset management department by designing, maintaining, and optimizing data systems related to mechanical assets. This role ensures that technical data is accurate, accessible, and aligned with operational, procurement, and bidding activities. The specialist will collaborate with engineering, procurement, and operations teams to manage a centralized repository of equipment specifications, pe...
Posted 3 weeks ago
4.0 - 6.0 years
0 Lacs
india
On-site
About this Position This role involves executing and supporting various quality assurance and compliance activities within the plant. Responsibilities include conducting process and product audits, managing hygiene and pest control programs, handling supplier complaints, and ensuring adherence to Health, Safety, and Environmental (SHE) regulations. The position also focuses on driving process improvements and supporting investigations related to quality and safety standards. What Youll Do Conduct process/product, hygiene, and warehouse audits; manage pest control program and ensure timely closure of findings. Attend daily quality meetings; report risks and follow up on 24/48-hour action item...
Posted 3 weeks ago
0.0 years
0 Lacs
ahmedabad, gujarat, india
On-site
Job Description Responsible to follow the preventive maintenance schedule of machine. Responsible to check UAF working in area. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in area. Responsible to fill the logs, BMRs and documents of area as per SOP and work execution. Responsible to operate the machines and vessels of area as per SOP. Responsible for cleaning and sanitization of area as per SOP. Responsible for line clearance activity before commencing the operations as per SOP. Responsible to Vial washing, Aseptic vial filling, Aseptic bag filling, autoclave and compounding ,vial washing and dehydrogenation tunnel Ski...
Posted 3 weeks ago
15.0 - 20.0 years
20 - 30 Lacs
chennai
Work from Office
Roles and Responsibilities 1. Responsible for implementation & monitoring of cGMP/GDP practices at site. 2. Responsible for periodic review of all quality Documents for appropriateness. 3. Preparation of SOPs and handling of QMS tools like deviation change control, CAPA. 4. Responsible for approval/rejection of deviations /change controls pertaining to corporate activities. 5. Oversee the team of technical personnel handling order processing artworks finalization BOM updating of products and follow ups. 6. Responsible for co-ordination and submission of Quality documents for regulatory submissions. 7. Responsible for maintenance, periodical update and review of technical agreements with dome...
Posted 3 weeks ago
6.0 - 8.0 years
6 - 11 Lacs
kadi, ahmedabad
Work from Office
Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available for daily commute) Note: Immediate joiners will be preferred first
Posted 4 weeks ago
3.0 - 7.0 years
2 - 4 Lacs
nalagarh, baddi
Work from Office
We have urgent Requirement for : Department : Quality Assurance Designation : Executive Skills Required : Process Validation, Equipment Qualification, QMS, APQR, Capa, Cleaning Validation. Experience Required : 03 to 08 years Salary : Depend upon Interview Location : Nalagarh interested candidate can contact @ 7717304694 or can send their Resume at hr2@theonpharma.com
Posted 4 weeks 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
4.0 - 8.0 years
8 - 13 Lacs
chennai
Work from Office
Role & responsibilities Job Title Manufacturing Engineer/Process Validation Engineer Location – Chennai Delivery looking immediate joiner only Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP). Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement. Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance. Support remediation activities including process updates, validation efforts, documentation revisions, and training plans. Strong understanding of regulatory ...
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
andhra pradesh
On-site
As a Manufacturing Manager at Pfizer, your role will involve overseeing the manufacturing of sterile dosage products. You will be responsible for various key activities including: - Facilitating investigation processes, proposing and implementing Corrective and Preventive Actions (CAPA). - Demonstrating knowledge of DMAIC and ALCOA principles. - Managing equipment, technologies, and unit operations involved in liquid injectable manufacturing. - Engaging and inspiring the team to meet performance expectations and coaching them using Coaching Skill principles. - Overseeing critical area management and governing clean room behavior and practices. - Implementing process and cleaning equipment va...
Posted 1 month ago
4.0 - 6.0 years
4 - 5 Lacs
mumbai
Work from Office
Responsibilities: Ensure compliance with regulatory requirements through CSV processes. Implement LIMS, Labware Lims & DMS systems. Conduct CSV activities for equipment validation. Health insurance Annual bonus Provident fund Flexi working
Posted 1 month ago
5.0 - 10.0 years
5 - 8 Lacs
jadcherla
Work from Office
Key Responsibilities: 1. Execution of Plant-Level Validation Activities Coordinate and execute process validation, cleaning validation, and hold time studies on shop floor. Monitor and record critical process parameters (CPPs) during validation batches. Ensure adherence to batch manufacturing records (BMRs) and protocols during execution. 2. Documentation & Review Prepare and review process validation protocols, reports, and summary documents . Maintain validation documentation as per SOPs and data integrity requirements. Compile analytical results and production data for validation reports. 3. Compliance & GMP Adherence Ensure execution is in compliance with SOPs, cGMP, and regulatory guide...
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Manufacturing Specialist in our company, your responsibilities will include: - Performing line clearance activities before commencing operations to ensure a clean and sanitized visual inspection and Packing area - Following the preventive maintenance schedule of machines - Operating the machines efficiently and filling the log of general areas as per SOP and work execution - Adhering to cGMP, GDP, and maintaining discipline in the department - Ensuring that all employees comply with the same standards Your role will also involve: - Ensuring that all equipment and production lines are in validated and calibrated status - Preparing daily production reports based on achieved targets - Crea...
Posted 1 month ago
2.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
Role Overview: As a Packaging Planning Executive in the Sterile Manufacturing Department, your primary responsibility will be to prepare packaging planning on a monthly and daily basis based on material availability. You will also be responsible for updating self-hygiene practices, attending training sessions, and working in accordance with standard operating procedures. Key Responsibilities: - Prepare packaging planning on a monthly and daily basis according to material availability - Update self-hygiene practices - Attend training sessions as per schedule and ensure compliance with Training Needs Identification (TNI) - Adhere to standard operating procedures in the general area of the Ster...
Posted 1 month ago
10.0 - 15.0 years
9 - 16 Lacs
baddi
Work from Office
Job Description: Ensure GMP compliance. Issue formats & protocols for Process Validation and Hold Time Study. Prepare protocols and reports for Process Validation & Hold Time Study; compile related data. Maintain all process validation documents along with batch records. Perform Process Validation activities on the shop floor. Maintain qualification records as per requirements. Execute equipment software and system qualification & re-qualification activities under supervision and coordination with concerned departments. Prepare QA SOPs. Ensure discipline within the department. Handle incidents, deviations, change controls, and CAPA. Prepare, review, and approve Cleaning Validation Matrix. Pr...
Posted 1 month ago
5.0 - 8.0 years
4 - 9 Lacs
pune
Work from Office
Roles and Responsibilities Execute equipment qualification, validation, cleaning validation, vendor qualification activities according to SOPs and regulatory requirements. Conduct process validation protocols, reports preparation, and review of documents. Ensure compliance with cGMP guidelines during execution of QA activities. Collaborate with cross-functional teams to resolve issues related to QA operations. Maintain accurate records of all QA activities and documentation.
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
nagpur, maharashtra
On-site
Role Overview: At Unijules Life Sciences Ltd., we believe in the immense potential for growth and innovation in the pharmaceutical industry. As new technologies continue to emerge, we understand the importance of expertise and skill to stay ahead in this rapidly evolving field. We provide a learning platform for individuals who are energetic, enthusiastic, and dedicated to learning and excelling in their careers. If you are committed to growth, development, sincerity, and quality, we welcome you to join the Unijules Pariwar family. Key Responsibilities: - Conduct audits in the pharmaceutical manufacturing plant, preferably specializing in Liquid/Solid dosage. - Implement cGMP system to ensur...
Posted 1 month ago
6.0 - 8.0 years
6 - 11 Lacs
kadi, ahmedabad
Work from Office
Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available for daily commute) Note: Immediate joiners will be preferred first
Posted 1 month ago
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