Storage qa 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... 

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,...

 ...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... 

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...

 ...Management Identify and qualify new vendors, ensuring they meet regulatory and GMP standards. Conduct vendor audits (in coordination with QA/Regulatory teams). Establish long-term supply agreements with key suppliers to ensure continuity and quality. Monitor supplier... 

 ...international). 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... 

 ...packaging materials comply with national and international regulatory requirements (e.g., CDSCO, USFDA, EU-GMP, WHO-GMP). Coordinate with QA/RA teams to ensure documentation and traceability. Stay updated with regulatory changes related to pharma packaging. 4. Innovation and... 

 ...reconciliation. Coordinate and execute stability sampling as per requirement. Coordination for execution of CAPA plan/risk mitigation plan, QA Oversight GLP and Self inspection plan Annual Product Quality Review (APQR) reports of all products manufactured at CPL biotech facility... 

Sales & Operations Planning: Conducting Sales & Operations Planning meetings (Pre-S & OP and S & OP), to providing visibility and communication on sales, demand, distribution, and supply trends in support of business growth. Close coordination with Logistics Team for timely...

 ...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... 

1. Method verification of new HPLC method for all stages of new molecule as well as modified old molecule method as per regulatory guidelines. 2. Calibration and maintenance of HPLC systems as per SOP. 3. Maintaining records for all analytical reports by entering all the data...

' Follow cGMP and GLP practices in Quality Control Lab. To follow safety procedure in qc department. To analyze the Sample of in process validation and finish product on instrument such HPLC, GC, UV, FTIR etc. by following test procedure. To attend the training as per schedule...

 ...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... 

To check on line in process parameters like temperature, RH, fill volume, quality of sealing at specific interval as mentioned in respective MMDI and SOPs and record the same in BMR To do compounding activities and dispensing activities. To check the vial washing machine, vial...

- Planning and execution of In-process, Bulk and finished product and Stability analysis of all recombinant proteins using different analytical techniques: HPLC, Protein quantification, Gel electrophoresis, Western blot and Dot blot, ELISA - Protein expression and characterization...

Follow cGMP and GLP practices in Quality Control Lab. To analyze the Sample of raw material on non-chromatographic instrument such as FTIR, UV, Polarimeter, KF, Autotitrator etc. by following test procedure. To attend the training as per schedule. To follow safety procedure...

Follow cGMP and GLP practices in Microbiology lab- Main pharma QC laboratory. To analyze the Sample of RM, Validation, FP, in process, Stability for Microbiological analysis by respective specification and SOP. To follow safety Procedure in Microbiology laboratory (Main Pharma...

Major purpose of the Job: 1) To developed Analytical Method Development, Routine analysis and Validation by GC & GC-MS 2) To maintain and observe cGLP and cGDP in working environment in GC & GC-MS. 3) Timely respond development of the Regulatory Queries of products. 4) Preparation...

- Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records for Biologics - Performing the production activities of Biosimilar Drug Substance - Operation of 5L, 100L and 1500 L fermenter - Operation of Protein...

1) Based on production requirement generate the production plan for next 3 month. 2) Run MRP for next 3 month in System (SAP) 3) Share the shortages to RM / PM based on requirement to Purchase team. 4) Discuss and coordinate with purchase team for timely supply RM / PM 5) Discuss...

To perform In-process Quality Assurance for the process / products being manufactured and packed in Main Pharma Block (Tablet / Capsule). To ensure Quality and cGMP compliance of the products being manufactured and Packed in Main Pharma Block (Tablet/Capsule). To give area ...

 ...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... 

 ...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... 

Responsible for small volume parenteral manufacturing activities at Dholka premises. To check hygienic condition of the workmen before entering to aseptic area, processing area and compounding area and maintain record. To check and ensure entry exist procedure of workmen with...

New Product Development of Domestic, ROW and EU markets Revision of Products of Domestic, ROW and EU markets as per Requirements of various stake holders PM selection, Machinability as per existing Automization of the pack Cost competitive pack development Monitoring of Stability...

' Responsible For rDNA manufacturing and Parenteral mfg activities at Dholka premises To ensure personal hygiene of the workmen before entering to aseptic area and maintain record. To check and ensure that aseptic area workmen are following entry exist procedure properly. To...

This role would be part of Analytical Research & Development for Formulations Research team. The key responsbilities would be as mentioned below: Analytical methods validation and report preparation on LCMS (for Nitrosamine impurities, NDSRI impurities etc.) Analytical Method...

To execute the technology receiving activities and QMS related activities at manufacturing plant. To support alternate vendor batch execution, process improvement, change in batch size, troubleshooting at shop floor, equipment change activities of product after technology transfer...

Follow cGMP and GLP practices in quality control lab. To analyze the Sample of any 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...