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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 days ago
0.0 years
1 Lacs
rupnagar
Work from Office
Role & responsibilities Checking all Batch production records/cleaning records for completeness and correctness. Reporting all production deviations and assisting in investigation of critical deviations. Performing activities as per respective SOPs with maintaining their records. Maintaining discipline, morale, motivation of subordinates. Ensuring compliance to Safety procedures and to maintain facility & documents always in auditable condition. Ensuring timely completion of assigned trainings in LMS of self and subordinates. Taking print/reprint of Batch production records/cleaning records from the BPR Printing system according to requirement (Based on authorization). Initiation & closure o...
Posted 1 day ago
2.0 - 6.0 years
3 - 6 Lacs
ahmedabad
Work from Office
equipment utility qualification process validation. cleaning validation. periodic qualification. Continued process validation. Annual Product review. Validation Master Plan. Packing Validation. Computer System Validation/ PLC validation
Posted 2 days ago
1.0 - 4.0 years
2 - 3 Lacs
vadodara
Work from Office
Responsibilities: Maintain QMS. Calibration Process & cleaning validation Conduct & document annual training Pest Control Review BMR & BPR APQR Change Control CAPA Deviation Eqp. Qualification Perform other quality tasks as instructed by Manager Office cab/shuttle Annual bonus Provident fund Job/soft skill training Travel allowance House rent allowance
Posted 2 days ago
3.0 - 7.0 years
0 Lacs
ahmedabad, all india
On-site
Role Overview: You will be responsible for bacterial vaccine manufacturing in the Drug substance Upstream and Downstream processes. This includes operations such as seed germination, fermenter operations, harvest, centrifugation, and cleaning validation activities. You will have the opportunity to work with Bacterial Toxoid vaccine manufacturing for vaccines such as Typhoid, Tetanus, Diphtheria, and Pertussis. In the Downstream process, you will be involved in purification operations like cell lysis, homogenization, TFF, chromatography, centrifugation, and sterile filtration. Working under cGMP facility and exposure to regulatory audits are essential requirements for this role. Key Responsib...
Posted 2 days ago
4.0 - 9.0 years
4 - 9 Lacs
ahmedabad
Work from Office
Role & responsibilities: Your job responsibilities are listed below for your understanding and acceptance. In case of any system up-gradation in future, you will be simultaneously re-trained to understand the new implementation. 1. Responsible Manufacturing of Oral Liquid and for Production planning as per order or availability of material. 2. Responsible for Preparation of BMR for new product. 3. Responsible for verifying the filled BMR and yield reconciliation of each stage. 4. Responsible for preparation of Standard Operating Procedure (SOPs). 5. Responsible for Preparation MFR for new product development. 6. Responsible for coordinating with Eng. department for Preventive maintenance. 7....
Posted 4 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 4 days ago
8.0 - 13.0 years
27 - 31 Lacs
chennai
Work from Office
About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.valgenesis.com/about About the Role: Responsibilities: Strategic Leadership & Portfolio Direction Define and lead the product strategy for Cleaning Validation, Analytical Method Validation, and Process Validation lifecycle within the SmartGxP plat...
Posted 5 days ago
5.0 - 10.0 years
5 - 15 Lacs
nanjangud
Work from Office
Introduction: Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Biosys Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research D...
Posted 5 days ago
0.0 - 3.0 years
1 - 2 Lacs
vadodara
Work from Office
Maintain QMS. Calibration Process & cleaning validation Conduct & document annual training Pest Control Review BMR & BPR APQR Change Control CAPA Deviation Eqp. Qualification Perform other quality tasks as operationally required
Posted 5 days ago
5.0 - 9.0 years
0 Lacs
dhar, madhya pradesh
On-site
As a candidate for the position, you should possess the following qualifications and skills: Role Overview: You will be responsible for handling Regulatory Knowledge and audit processes, including Cleaning Validation. Additionally, you will need to demonstrate a sound understanding of Non-sterile dosage forms. Your role will also involve tasks such as preparing Risk Management and Cross-contamination control strategies. Furthermore, you will be expected to manage the Change Management system effectively. Key Responsibilities: - Possess good communication skills - Demonstrate Regulatory Knowledge and audit handling exposure - Have working exposure of Cleaning Validation and respective work ar...
Posted 6 days ago
4.0 - 8.0 years
4 - 8 Lacs
chennai
Work from Office
Roles and Responsibilities Responsible for Quality System Review & Improvements Handling and control of Non-conforming products. Responsible for review & approval of key Quality System Procedures, Standard Operating Procedures & other Master Documents. GAP Analysis of the process and products. Identifying the scope of improvement based on trend analysis. Putting forward the suggestions for improvements to the Management. Participation in audits, compliance and Tracking of Audit Compliances/Status. Review & closeout of Change Controls, Deviation Complaints & CAPA. Participating in Impact assessment, investigation & approval of deviations. Review & Approval of change controls, Deviations, OOS,...
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Document Specialist, your primary role will be to work in collaboration with US team members to create high-quality documents and ensure timely delivery of outputs consistently. Your key responsibilities will include: - Preparing and reviewing PPQP, PPQR, PSP, PSR, CPVP, BBHS, and regulatory modules for submission/validation batches. - Creating and reviewing Cleaning Validation documents such as Matrix, CVP, CVSR & CVRs, and monitoring the Annual Cleaning Verification Program, DEHT & CEHT. - Handling CC, UD, PD, Event, and Customer complaints as needed. - Preparing and reviewing documents for manufacturing and packaging activities, including MPR, PBR, MPS, SOP, and other related documen...
Posted 1 week ago
4.0 - 8.0 years
4 - 8 Lacs
bengaluru
Work from Office
We are looking for a highly skilled and experienced professional to join our team as an Executive Quality Assurance Operations at APOTEX PHARMACHEM INDIA PRIVATE LIMITED. The ideal candidate will have a strong background in quality assurance operations and a proven track record of ensuring compliance with regulatory requirements. Roles and Responsibility Develop and implement quality control processes to ensure compliance with regulatory standards. Conduct regular audits to identify areas for improvement and implement corrective actions. Collaborate with cross-functional teams to resolve quality-related issues and improve overall process efficiency. Analyze data to identify trends and opport...
Posted 1 week ago
0.0 years
0 Lacs
ahmedabad, gujarat, india
On-site
Job Description To work in collaboration with US team members to create the highest quality documents and timely delivery of outputs consistently. Prepare and review PPQP, PPQR, PSP, PSR, CPVP, BBHS, regulatory modules (for submission/validation batches). Prepare and review Cleaning Validation documents (Matrix, CVP, CVSR & CVR's) in addition to timely monitoring of Annual Cleaning Verification Program, DEHT & CEHT. Handling of CC, UD, PD, Event and Customer complaints as and when required. To prepare and review documents for manufacturing and packaging activities which includes but not limited to MPR, PBR, MPS, SOP and other manufacturing and packaging related documents. Prepares technical ...
Posted 1 week ago
3.0 - 6.0 years
1 - 2 Lacs
hyderabad
Work from Office
Handling of QMS actives, Change control Deviations market complaints BPR review Process validation review Cleaning validation review APQR preparation Qualification Groups Graduation B.Sc Post Graduation M.Pharma Post Graduation M.Sc Graduation B.Pharma Graduation D Pharmacy
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
navi mumbai, maharashtra
On-site
Role Overview: As a Quality Assurance Officer at our company located in Tajola, Mumbai, you will be responsible for maintaining quality standards by ensuring the issuance of all relevant documents related to Quality Management System (QMS), Batch Manufacturing Record (BMR), Equipment Cleaning Record (ECR), specifications, MOA, TDS, formats, and Standard Operating Procedures (SOPs). Your role will also involve the preparation, review, and distribution of SOPs, reviewing Batch Manufacturing Records and Equipment Cleaning Records, handling Change Control Systems, deviations, and out-of-specification issues, as well as preparing the Annual Product Quality Review. Additionally, you will be involv...
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
As a skilled QA Executive / Officer joining the Quality Assurance team, you will be responsible for various key tasks including: - Conducting gap analysis against QA SOPs, preparing and revising SOPs using Control Document Management System (CDMS), and conducting classroom training sessions for approved SOPs. - Preparing annual internal audit schedules, conducting internal audits, and preparing audit reports. Raising CAPAs in TrackWise and verifying effectiveness post-implementation. - Preparing Periodic Product Review (PPR) for assigned products as per regulatory expectations. - Supporting contract manufacturing sites during product transfers and validations. - Performing change control ass...
Posted 1 week ago
3.0 - 6.0 years
2 - 6 Lacs
hyderabad
Work from Office
Greetings of the day ! Our reputed MNC Client is hiring for: Position: Production Documentation Location: Unit-1 is situated at Bonthapally village in Medak District, ( Hyderabad) Transport is available Notice Period: Immediate/ 15 days/ 30 days Shift: Day Shift ( Rotational Shifts ) Work Mode: 6 days working ( Work From Office ) Interview Mode:- F2F for Hyderabad candidates Virtual interview for outstation candidates Job Description Role : (Chemist / Officer) , Production Documentation. Education Qualification: B . Sc / Diploma Chemical / M.Sc Experience Required: 3-6 years. Roles & Responsibility : Having good knowledge in QMS, OOT, OOS, Deviation, CCF, Validation, process validation, clea...
Posted 1 week ago
8.0 - 10.0 years
6 - 8 Lacs
udaipur
Work from Office
Implementation and oversight of Quality Management System (QMS) Validation activities including Cleaning Validation and Process Validation Handling Deviations and Investigations related to quality issues Conducting and preparing for Internal and External Audits compliance with regulatory standards and company SOPs Coordinating with production and other departments for quality assurance
Posted 1 week ago
4.0 - 8.0 years
5 - 8 Lacs
hyderabad
Work from Office
Hiring experienced IPQA professionals (48 years) for OSD formulation unit. Job Responsibilities: Line clearance, in-process checks, documentation (BPRs / Logbooks), Empower-3, Analytical Data Review, and QMS activities. Perform in-process checks during granulation, blending, compression, encapsulation & coating. Monitor IPC parameters: LOD, bulk density, blend uniformity, we Provide line clearance for manufacturing & packing operations Review BMR/BPR and ensure real-time documentation as per GMP/GDP . Verify equipment cleaning and ensure absence of cross-contamination . Conduct online sampling and coordinate with QC for testing. Support process validation & cleaning validation for OSD equipm...
Posted 2 weeks ago
0.0 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 Perform method verification/validation of compendia/pharmacopeial updations, Me...
Posted 2 weeks ago
7.0 - 12.0 years
5 - 10 Lacs
chennai, thiruvallur
Work from Office
The QMS Lead / Head is responsible for establishing, implementing, and maintaining a robust Quality Management System in compliance with USFDA, WHO , and other global regulatory requirements. The role ensures that vaccine manufacturing operations meet applicable GMP standards, inspection expectations, and quality risk management principles Key responsibilities: Lead implementation, maintenance, and continual improvement of the site QMS in alignment with ICH Q10, WHO TRS, and USFDA 21 CFR Parts 210/211/600. Ensure continuous inspection readiness for WHO-PQ , USFDA , EMA , CDSCO , and other regulatory agency audits and Lead preparation of inspection plans, SME readiness, and gap assessments. D...
Posted 2 weeks ago
8.0 - 12.0 years
0 Lacs
hyderabad, telangana
On-site
Role Overview: Azurity Pharmaceuticals, a specialty pharmaceutical company, is seeking a motivated individual to join their Technical Operations team. As a key player in managing technical process strategy, this role involves overseeing product deliverables in alignment with company objectives. You will lead a team to achieve project milestones supporting process scale-ups, technical transfers, and investigation of deviations for commercial products. Key Responsibilities: - Manage manufacturing planning and execution, including qualification and validation activities for both development and commercial products. - Develop and review controlled documentation for late-stage development, qualif...
Posted 2 weeks ago
5.0 - 10.0 years
5 - 11 Lacs
vadodara
Work from Office
Job Title: IT Projects Implementation team member Business Unit: Tandalja Job Grade Sr. Executive IT- G11B Location: Tandalja At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Key responsibilities: Lead assigned rol...
Posted 2 weeks ago
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