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3.0 - 6.0 years
1 - 4 Lacs
Vasai
Work from Office
1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory department. 6. Working Hands on MARKET COMPLAINTS and CAPA. 7. Preparation of Master Formula Record (MFR) and Preparation Of (SOPs). 8. Preparation of EQUIPMENT QUALIFICATION documents i.e. IQ, OQ, PQ protocol and Reports during Installation of New Instruments/ Equipments. 9. Identification of Hazard and Calculation of Risk associated with product or daily activity. 10 Participation and Handling of SELF INSPECTION Reports (INTERNAL AUDIT). 11. Preparation of Audit & Maintenance of Post Audit Documents (compliance reports). Desired Candidate Profile Bachelor's degree in Science (B.Sc) or Pharmacy (B.Pharma). Male candidate will be preferred.
Posted 5 hours ago
4.0 - 7.0 years
0 - 0 Lacs
Homnabad
Work from Office
Key Responsibilities:** - Conduct thorough testing and validation of [products/processes, e.g., software applications, pharmaceutical formulations, or manufacturing processes] to ensure compliance with quality standards. - Develop and execute QA test plans, protocols, and reports. - Identify, document, and track defects, ensuring timely resolution. - Collaborate with cross-functional teams to maintain quality throughout the product lifecycle. - Ensure adherence to regulatory standards (e.g., ISO, GMP, or other relevant certifications). - Contribute to process improvements and quality assurance strategies. **Skills Required:** - Strong knowledge of QA methodologies, tools, and processes. - Familiarity with [specific tools/software, e.g., Selenium, JIRA, or GMP protocols]. - Analytical mindset with attention to detail. - Excellent communication and teamwork skills.
Posted 3 weeks ago
6.0 - 8.0 years
6 - 10 Lacs
Jammu
Work from Office
Role & responsibilities protocol Preparation, review and execution for plant qualification preparation of process validation protocol, preparation and compilation of validation report co-ordinate for 3rd party calibration risk assessment preparation annual product review QMS, Change control, DEviation Preferred candidate profile B.Pharma/M.Sc with minimum 6-8 yrs experience in QA. candidate must have exposure of working in regulatory pharma plant.
Posted 3 weeks ago
5.0 - 10.0 years
5 - 12 Lacs
Faridabad
Work from Office
Lead end-to-end product development projects in alignment with customer requirements and company objectives CAD tools used; manage BOM, DVP, and APQP documentation Drive prototype development, testing, and validation activities for new products Required Candidate profile Strong understanding of APQP, PPAP, FMEA, GD&T Must Have Experience in Sheet Metal Industry Experience with Tier 1 & 2 automotive suppliers is highly preferred Proficient in SolidWorks, AutoCAD
Posted 3 weeks ago
2.0 - 5.0 years
4 - 5 Lacs
Nalagarh
Work from Office
Responsibilities: * Ensure compliance with regulatory requirements through quality control measures * Conduct process validations, cleaning verifications & change controls * Prepare validation protocols & reports
Posted 3 weeks ago
16.0 - 24.0 years
20 - 30 Lacs
Ahmedabad
Work from Office
Greetings from Kashiv Biosciences!!!! We are looking for Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Validation and QMS activity. , Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness. Responsible for technical agreements with vendors who have work at Plant premises. Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled. Responsible for change control/deviation management/CAPA Through Track wise management System. Facing the Regulatory, Customer, Internal Audits and preparation of compliance. SOPs and Protocols Training for the new personnel and refreshment training for existing team members. Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works. Candidate Details The candidate should be from Pharma industry only having exposure to Parenteral/ Injectables. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences
Posted 3 weeks ago
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