Qa validation jobs in Dholka

 ...schedule. To ensure daily production report and submit to higher management. To ensure periodic qualification of equipment and process validation are carried out as per schedule. Raise the change control for new equipments installation and completed the I.Q, O.Q and P.Q of new... 

 ...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... 

 ...existing products. Timely execution of scale up/ exhibit/process validation of allotted projects. Process improvement and troubleshooting of...  ...coordinate with CFT team like AR Lab, Production, Manufacturing, QA/QC for timely completion of project. Ensure timely address of regulatory... 

 ...To ensure daily production report and submit to higher management. To ensure periodic qualification of equipment and process validation are carried out as per schedule. Raise the change control for new equipments installation and completed the I.Q, O.Q and P.Q of new... 

 ...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.... 

 ...Protein expression and characterization analysis by HPLC for different recombinant vaccines projects. - Analytical method development and Validation for recombinant vaccines as per guidelines. - Data compilation, evaluation and report preparation for the all experiments conducted.... 

 ...prepare and review documents like SOP, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. To initiate change management, CAPA and Deviations, and... 

 ...follow safety Procedure in QC department. To manage an accurate, reliable, efficient and timely review of finished products, in process/ validation, raw material, stability, GLP, Non-routine samples. To ensure timely review of batch audit trail, system audit trail, message center... 

 ...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... 

 ...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 development and report... 

 ...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... 

 ...packing operations. To perform sampling of In- process, finished product and retain samples as per respective MMD-I / BPR/SOP, Process validation/Hold Time/Packing Validation/Stability study as per respective protocols and to submit the samples to Quality Control for analysis.... 

 ...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...

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...

 ...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...

 ...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... 

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...

 ...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...

Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil and ROW market Preparation of query response of drug substance for various and less regulated markets and...

 ...Standard 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... 

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...

 ...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... 

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...