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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 4 weeks ago
7.0 - 12.0 years
35 - 50 Lacs
hyderabad
Work from Office
Job Summary We are looking for an individual to ensure strict adherence to safety protocols, SOPs, and quality standards, overseeing batch manufacturing activities, and coordinating with various departments to maintain operational efficiency. The role involves planning and executing production activities, coordinating with cross-functional teams, and ensuring compliance with regulatory requirements, critical for maintaining product quality and meeting production targets. Roles & Responsibilities • You will be responsible for adherence to company safety norms, policies, and SOPs (Standard Operating Procedures). • You will oversee batch manufacturing activities according to e-BMR instructions ...
Posted 4 weeks ago
10.0 - 20.0 years
10 - 15 Lacs
panvel, khalapur, raigad
Work from Office
Dear Candidates, We are looking for our USFDA & EUGMP approved plant located at Rasayani, Patalangana MIDC for Manager / Section Head IPQA. Role & responsibilities 1. To Lead IPQA activities. 2. Strategies, plan and organize the team's resources to perform day to day operations 3. Ensure Quality compliance as per CGMP requirement in manufacturing facility and inspection readiness at all times and represent in regulatory audits. 4. Review and approval of all SOPs, protocols, reports related to IPQA section. 5. To provide Line clearance by ensuring clearance of documents as per requirement. 6. To verify and coordinate In process and finished product, cleaning validation and any other sampling....
Posted 4 weeks ago
3.0 - 8.0 years
2 - 7 Lacs
aurangabad
Work from Office
Responsibilities: Conduct HPLC, GC, UV, water analyses per BMRR. Implement change controls, manage deviations. Perform API manufacturing, intermediate handling, SRP processing.
Posted 4 weeks ago
2.0 - 3.0 years
5 - 9 Lacs
bengaluru
Work from Office
Job Title: Internal Audit Analyst Management Level: 11 Analyst Location: Bangalore Must have skills: Chartered Accountant with 2 - 3 years of post-qualification experience in external or internal auditing, preferably in Big 4 or a global organization. Good to have skills: Internal Audit experience with Big 4 or a global organization Job Summary : An agile, highly motivated, innovative thinker with a background in audit, risk, or compliance looking to join a fast-paced, global Internal Audit department that has embraced transformative capabilities including advanced analytics, dynamic risk assessment, and automation to retain its role as a trusted advisor to the business. You are looking to b...
Posted 4 weeks ago
2.0 - 5.0 years
1 - 3 Lacs
mumbai, thane, navi mumbai
Work from Office
Position: QA Executive Job Location: Nerul, Navi Mumbai Industry: Ayurvedic / Herbal Pharmaceuticals Qualification: B.Pharm /M. Pharm Designation & Salary: Commensurate with industry experience and expertise. Working Days And Time: 8:00 AM to 5 PM / 6 Days week / Sunday fixed Off. Key Responsibilities: Preparation and implementation of Standard Operating Procedures and Documentation like preparation of MFR, BMR, BPR, all types of Validation, Stability study protocols and reports. To implement and enforce cG.M.P. as per statutory requirements Giving feedback to management regarding discrepancies, deviations and any special matter. To attend external official work, seminars, meetings, discussi...
Posted 4 weeks ago
5.0 - 9.0 years
2 - 5 Lacs
hyderabad
Work from Office
The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures t...
Posted 4 weeks ago
5.0 - 10.0 years
5 - 11 Lacs
gurugram
Work from Office
Department: R&D Quality (GPvP QA) Designation: Executive (QA Pharmacovigilance) Location: Gurgaon JOB DESCRIPTION (JD) Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor/co-auditor for outsourced parties (CROs, Service Providers, Vendors), Affiliates & Partners etc., associated with Sun Pharma Pharmacovigilance operations. Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems. Management of Internal Audit Observation Database (IAOD) with the perspective of sharing audit repo...
Posted 4 weeks ago
8.0 - 13.0 years
1 - 5 Lacs
hyderabad
Work from Office
What you will do In this vital role as Specialist Business Analyst as part of Operations Generative AI (GenAI) Product team to deliver cutting edge innovative GEN AI solutions across various Process Development functions(Drug Substance, Drug Product, Attribute Sciences & Combination Products) in Operations functions. As part of this role, you both engage with the business users and partners to elicit requirements and perform data analysis and metrics definition activities as part of a product team of key stake holders, data scientists, business analysts, and software engineers. Roles & responsibilities Collaborate with System Architects and Product Managers to manage business analysis activi...
Posted 4 weeks ago
2.0 - 7.0 years
2 - 7 Lacs
hyderabad
Work from Office
Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 8 years of experience for the below positions at its Vaccine Business, Shamirpet, Hyderabad: Designation: Sr. Executive/Executive/Sr. Officer/Officer Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI PRODUCTION BULK MANUFACTURING (DRUG SUBSTANCE / ANTIGENS) Desired Experience: Applicants with relevant experience in vaccine, biosimilars, or injectable manufacturing will be considered. Perform upstream and downstream activities for bacterial or viral antigens. Execution of production batches in both upstream and downstream areas. Focus on timely execution to ensure that the proces...
Posted 4 weeks ago
5.0 - 6.0 years
7 - 8 Lacs
mumbai
Work from Office
Nocpl is looking for Dedupe Officer to join our dynamic team and embark on a rewarding career journey. The Dedupe Officer ensures data integrity by identifying, analyzing, and removing duplicate records from customer or operational databases. They perform routine data checks, validate information accuracy, and maintain clean master data for compliance and reporting purposes. The role includes coordinating with various departments to correct inconsistencies, standardizing data formats, and implementing automated tools to prevent duplication. They also generate reports highlighting data hygiene levels and recommend process improvements to maintain database accuracy and efficiency. Disclaimer :...
Posted 4 weeks ago
7.0 - 10.0 years
3 - 5 Lacs
baddi
Work from Office
Sr. Executive IPQA Location- Baddi Experience- 7+ years in injection plant Salary Package- 40-50 K Interested one share resume on 9815675900
Posted 1 month ago
1.0 - 6.0 years
2 - 7 Lacs
kalol, mehsana, ahmedabad
Work from Office
Role & responsibilities Manufacturing area:- Line clearance before start of batch processing and after cleaning. In-process checks during manufacturing stages Verification of machines settings, process parameters and yield reconciliatoin Sampling of in-process materials for testing. Monitoring of environmental conditions and compliance during production Verification of online entries in BMR Packing area: Line clearance before start of packing and after product/pack change over. Monitoring batch coding, overprinting, labeling, and packaging operations Performaning in-process checks - correct packing components, label reconciliation, and proper sealing. Monitoring controlled area discipline, g...
Posted 1 month ago
2.0 - 5.0 years
3 - 7 Lacs
naidupet
Work from Office
Role & responsibilities APLHC Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Control/Quality Assurance Experience Required: 1 - 6 years in USFDA Approved pharmaceutical manufacturing facility Quality Control and Quality Assurance Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: QC Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc. Prepare/standardize analytical methods, calibration & instrument qualification (IQ/OQ/PQ) Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry Investigate OOS/OOT results and implement effective CAPA Support regulatory, customer and internal audits...
Posted 1 month ago
7.0 - 8.0 years
14 - 18 Lacs
pune
Work from Office
Here is how, through this exciting role, YOU will contribute to BMC's and your own success: You like to develop, design, and deliver solutions that deliver sustained business value from our and associated solutions You enjoy working cross-functionally across Sales, Marketing, Operations, and IT organizations for supporting the customer success organization Youre a team player and believe in building synergies across BMC to create/continually evolve one integrated customer journey You like to innovate, and have an appetite for solving business problems, to continuously improve our quality of service You have a passion for development, and challenge yourself to learn new things You know how to...
Posted 1 month ago
2.0 - 5.0 years
2 - 4 Lacs
vadodara
Work from Office
Role & responsibilities : Ensure cGMP and GDP practices are followed in the respective facility work areas. Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR). Conduct in-process checks and line clearance at various batch manufacturing stages (Manufacturing, Filtration, Filling, Sealing). Review executed batch records for completeness and accuracy. Collect samples at different stages of batch manufacturing, including in-process and finished product sampling. Ensure shop floor compliance by reviewing equipment usage logbooks. Oversee validation activities such as Aseptic Process Simulation (Media Fill) and Process Validation. Review Risk Assessments for equipment, inst...
Posted 1 month ago
8.0 - 10.0 years
7 - 9 Lacs
pune
Work from Office
Job Description Maintenance of GLP in the Laboratory Upkeep of Housekeeping in the Laboratory. Ensuring activity logs are maintained for all critical instruments /equipment’s. Timely preparation of Laboratory Documents. Timely review of analytical data generated in laboratory. Ensuring Analytical Technology transfer from transferring lab as per approved protocol. Review and approval of incident , out of specification ,out of trend report and approval of QC related activities. Involved in QAMS activities such as change control, CAPA , incidents, deviation etc. Approval of stability summery report. Timely review of Quality control procedures and initiation for up gradation of same. Compliance ...
Posted 1 month 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 1 month ago
2.0 - 10.0 years
0 Lacs
ahmedabad, gujarat
On-site
**Role Overview:** If you have the talent and zeal, an opportunity awaits you to join our Greenfield Injectable manufacturing plant at Ahmedabad in various roles such as Production, Engineering, Quality Assurance, and Quality Control. **Key Responsibilities:** - **Production: Shift In charge** - Supervising Injectable production with a B. Pharm/M.Pharm qualification and 3 to 10 years of experience. - **Production: Operator/Tech. Associate** - Operating in Injectable production with an I.T.I./ Diploma qualification and 2 to 8 years of experience. - **Engineering: Shift Incharge** - Handling Instrumentation, Plant maintenance, Engineering QMS for Injectable Manufacturing Plant with a B.E./B.Te...
Posted 1 month ago
1.0 - 3.0 years
2 - 3 Lacs
navi mumbai
Work from Office
Role & responsibilities 1. Line Clearance in all stages. 2. Sampling all stages. 3. Validation. 4. Control Sample Management 5. APQR 6. QMS Review. Interested Applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9867700982
Posted 1 month ago
2.0 - 7.0 years
3 - 7 Lacs
tirupati
Work from Office
Role & responsibilities Monitoring of preventive maintenance, Calibration, HVAC Validation and other Schedules Review of Temperature Mapping, Calibration Certificates Ability to handle Process, HVAC Validations and Equipment Qualifications Monitoring of Filter Cleaning and Differential Pressure of AHU's Review of Water and Environmental Trends Monthly and Yearly Handling of trackwise for QMS related activities Handling of Compliance wire for training related activities Preparation & Review of Annual Product Quality Review reports APQR Experience in handling audits Reviewing of Calibration schedule, Preventive maintenance schedules and Equipment qualification protocols and reports Reviewing o...
Posted 1 month ago
9.0 - 14.0 years
9 - 13 Lacs
pune
Work from Office
Engineering and Architecture of open source and commercial products Provide architectural leadership and support for existing and new technologies, assess business requirements, and create product roadmap, product standards and automation pipelines Expected to be running spinning off the effort from the ground and running it all the way through final implementation and operationalize the tool or product Provide technical support for business and client partners for product integrations Develop and document technical and non-technical infrastructure related processes
Posted 1 month ago
4.0 - 6.0 years
0 - 1 Lacs
dharwad, hubli, savanur
Work from Office
Job Responsibilities: 1. To carry out the in-process activities at Warehouse, Manufacturing, Primary Packing & Secondary Packing Areas & complete the documentation works online. 2. To allocate, check and monitor the In Process Quality Assurance work to all IPQA Personnels in absence of IPQA Manager. 3. To collect analysis sample like in-process, finished products, validation sample, control sample, stability samples (but not limited to), customer sample and submit to QC for analysis. 4. To withdraw & charge the Stability Samples as per the Stability Study Protocol & update the respective logbooks. 5. To review completed batch records for all enclosures, data entries etc. and submit to Head Q...
Posted 1 month ago
10.0 - 15.0 years
4 - 8 Lacs
pune
Work from Office
Post- Assistant Manager Quality Experience - 10 - 12 yrs Contact - 9356395439 Email - jobpune25@gmail.com Diploma / Degree in Mechanical Location Pune chakan
Posted 1 month ago
4.0 - 9.0 years
2 - 4 Lacs
aurangabad
Work from Office
Post- Junior Engineer Quality Assurance Email - jobpune12@gmail.com Contact - 9356395439 Experience - 04-08 yrs Edu - DME / BE Mechanical Location - Pune Pirangut Industry - Automotive JD Conduct in-process inspection of machined parts Manufacturing QA to ensure in-process quality, maintain compliance . Maintain IATF 16949, ISO 9001 & PPAP documentation and support audits. Prepare PDIR, 8D/RCA methodology QC tools, gauges, control plans, PPAP, ERP, and machining component Handle customer quality interactions .
Posted 1 month ago
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