Qa qc jobs in Dholka

 ...facility and keep it cGMP compliant 5. Involvement during regulatory audit preparation 6. Co-ordination with cross functional teams like QC, QA, Maintenance, Warehouse, Injection etc. 7. Training and mentoring new joinees 8. Keep the track for calibration and qualification... 

 ...submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of... 

 ...Packing Material specimen, Impurities, Reference Standards as per MOH requirement. 4. Establish Coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Submission of... 

 ...selection of vendor for new development by team. Discussion with new vendor for their capabilities, plants, terms etc. Ensure approvals of QA, QC, Plants for submitted Sample Vendor audit if required & negotiations Arrange commercial lot 3. Market Information Contacts with vendor... 

 ...requirements (e.g., CDSCO, USFDA, EU-GMP, WHO-GMP). Coordinate with QA/RA teams to ensure documentation and traceability. Stay updated...  ...evidence). 5. Cross-functional Coordination Work closely with R&D, QA/QC, production, and marketing to develop new packaging formats. Participate... 

 ...UID. Timely review of LNB and project files for allotted projects. To coordinate with CFT team like AR Lab, Production, Manufacturing, QA/QC for timely completion of project. Ensure timely address of regulatory deficiencies for Domestic and ROW Market. Compilation and review... 

 ...requirement. Coordination for execution of CAPA plan/risk mitigation plan, QA Oversight GLP and Self inspection plan Annual Product Quality...  ...QA from time to time. To ensure and verify GMP and GLP checks in QC and Manufacturing area of Biotech division. Any other activity assigned... 

 ...suppliers and evaluate new suppliers based on quality, cost, delivery, and service. Support vendor qualification audits in collaboration with QA/QC. 5. Compliance & Documentation Ensure SCM activities adhere to cGMP, GDP, and other regulatory requirements. Maintain records as per... 

 .... Negotiate contracts, pricing, and terms with vendors to secure favorable terms. Conduct periodic vendor audits in coordination with QA/QC to ensure compliance. 3. Budgeting & Cost Control Prepare annual purchase budgets and monitor adherence. Analyze market trends and pricing... 

 ...regulatory and GMP standards. Conduct vendor audits (in coordination with QA/Regulatory teams). Establish long-term supply agreements with key...  ...for all purchase transactions. Support cross-functional teams (QA/QC, RA) during internal/external audits. 4. Operational Purchasing... 

 ...all laboratory documents (Analytical reports). 8) Proper utilization of laboratory equipment and person day to day. 9) Support to F&D, QA, QC and RA for related to analytical issues. 10) Support to regulatory for the submission of dossiers query response. 11) Planning for New... 

 ...separately after discussion with LL team. 9) Closely coordinate with cross function department for Ach goal. 10) Daily discuss with Production / QC and purchase team for ach daily schedule. 11) To provide technical support for change management, investigations of deviations, CAPA... 

 ...packing material on instrument such as UV, IR , DSC , etc and physical test by following test procedure. To follow safety procedure in qc department. To maintain calibration records, cleaning records & log-sheet of instrument wise. Involve in any trouble shooting and problem... 

 ..., Polarimeter, KF, Autotitrator etc. by following test procedure. To attend the training as per schedule. To follow safety procedure in qc department. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample... 

To lead the Granulation department with respect to developing the second line. To ensure the delivery of products as per the production target. To ensure and monitoring yield, Wastage, WIP & operation expenses of Granulation area. To co-ordinate with tablet sub- department,...

 ...pricing to control costs. Assist in budget planning and implement cost-saving initiatives. 6. Cross-functional Coordination Work closely with QA/QC, production, finance, and regulatory teams. Resolve quality or delay issues with vendors in coordination with internal teams.... 

Ensure the cGMP Compliance and schedule M compliance in production. Ensure the proper utilization of men and machine of Granulation area. Ensure the training of production staff and worker. Ensure the development progress periodically of personals and take necessary...

 ...pricing to control costs. Assist in budget planning and implement cost-saving initiatives. 6. Cross-functional Coordination Work closely with QA/QC, production, finance, and regulatory teams. Resolve quality or delay issues with vendors in coordination with internal teams.... 

 ...sampling of bulk and finished product for each batch at the end of the batch as per SOP entry into sampling log and submit the samples to QC for analysis. Record review, To review the Batch Manufacturing Records for on line entries at each stage. To review sequential log of... 

 ...routine and stability sample analysis. Perform the analytical method verification / validation as per protocol. Analytical method transfer to QC Laboratory. Documentation as per the GLP requirement. Trouble shooting during day to day analysis with proper instrument care. Perform... 

 ...products as per pharmacopoeia and regulatory requirements. 4) Facilitate smooth and documented method transfer to the Quality Control (QC) lab, including training, protocol preparation, and data review. 5) Perform exhibit batch sample analysis from initial to end-of-shelf-life... 

 ..., and select the MRM - Plant Release sample and plant cleaning sample analysis by LC-MSMS, fill up TDS, and submitted COA at Ankleshwar QC - Routine LC-Mass Analysis for Intermediate, in process and Final API as per the Specification and Standard test procedure - Calibration... 

 ..., Polarimeter, KF, Autotitrator etc. by following test procedure. To attend the training as per schedule. To follow safety procedure in qc department. To receive the samples for analysis and making entry in Inward register. To maintain the Instruments log books related to sample... 

Major Purpose: (Exactly spell out key deliveries/results expected from this job) 1) Preparation of New product Specifications and Standard test procedures for ANDA, Export and Domestic markets. 2) Preparation of Routine revision Specifications and Standard test procedures for...

 ...functional team. To assist for transfer of RM/PM stock in SAP, due to on-line rejection. To assist for submission of the vendor samples to QC and maintain log of Sample Register. To assist for intimation of RM/PM rejection to purchase department for CAPA and maintenance of RM/... 

 ...working standard. To Maintain Inventory management for all chemicals, solvents and laboratory required items. To follow safety Procedure in QC department. Maintain all the chemicals opening date and expiry date Responsible for procurement of chemicals, glassware, stationary,... 

 ...from chambers as per the schedule Maintain all stability chambers daily temperature and humidity monitoring. To follow safety Procedure in QC department. Responsible for withdraw the stability sample for analysis as per schedule. To maintain stability study log book of... 

 ...Operating Procedures (SOPs). Monitor area-wise manpower allocation, machine utilization, and shift-wise productivity. Coordinate with QA/QC, maintenance, and warehouse departments for line clearance, sampling, and material movement. Ensure adherence to current Good Manufacturing... 

 ..., quality, service). Conduct supplier audits in collaboration with QA and Regulatory teams. Develop alternate and backup sources to reduce...  ...standards (USFDA, EU-GMP, WHO, etc.). Coordinate with QA/QC and Regulatory Affairs for technical documents: DMFs, COAs, MSDS, stability... 

Major Purpose of the job: 1. Preparation of New product specifications and standard test procedures for ANDA, Export and Domestic Markets 2. Preparation of Routine revision specifications and standard test procedures for ANDA, Export and Domestic Markets Principal tasks & responsibilities...