88 Api Production Jobs - Page 4

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. Lead, manage and develop leading edge regulatory strategies leading to successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required data packages and facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development activities to provide appropriate CMC as well as regulatory strategies. critical regulatory requirements to meet the quality submission and timely approvals. Responsible for all queries received from Agency or customers. Post-approval changes and Post approval compliance. communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Roles and Responsibilities Ensure compliance with cGMP guidelines during API production processes. Conduct BPR review meetings to ensure quality control standards are met. Oversee bulk drug manufacturing operations, including packaging and labeling. Collaborate with cross-functional teams to resolve issues related to production scheduling and inventory management. Maintain accurate records of production activities, batches, and equipment maintenance. Desired Candidate Profile 0-5 years of experience in API production or pharmaceutical industry. Strong understanding of BPR review procedures and regulations (cGMP). Excellent communication skills for effective collaboration with team members. Proficiency in MS Office applications.

Role & responsibilities In process / Intermediate / Raw Material test limits preparation as per MPR • Receive and safeguard Batch Production Record (BPR) from QA • Follow the appropriate Good Manufacturing Practices • Ensure that entire operations are being carried out in a prescribed manner • Handle the Non-Confirming product as per the Shift-In charge • Follow the transfers of intermediates/ Final Product/ finished product to appropriate storage area • Record any deviation or abnormality in the batch production records during the process and inform the same to Shift-In charge • Prepare the deviation report for standard time deviations and deviation of BPR operations during the process • Responsible for calibration of equipment and cleaning activities • Participate in performance qualification of the equipment • Responsible for checking the intermediate analytical reports status during the process • Responsible for filling the reduce/skip testing format • Check yield calculations in CPR • Prepare protocol request from and fill the data in protocol forms • Involved in storage tanks periodical inspections • Prepare the Finished product transfer note Preferred candidate profile 1-3 years experience in API Manufacturing

Role & responsibilities 1. To procure Raw materials from Ware house 2. Carry out the manufacturing operations according to the BPCR provided by QA department 3. Perform the Operations in accordance to the established SOPs and cGMP and capture the data in relevant documents. 4. To maintain for Good documentation practise at work place ( ALCOA) 5. To ensure the entry of batch related details in ERP. 6. To execute batches every day as per the Production planning schedule.

Role & responsibilities Operation of all production equipments, execution and monitoring the process as per BMR during shift hours. To perform all the calibration activities for W.B and holding tanks receivers as per SOP and maintain calibration records as updated. To monitor overall plant parameters & utilities. To control the spills, salvaging of spills in the plant. To ensure personal hygiene inside the plant. To ensure all the chemicals are handled as per MSDS. Ensure to maintain online documentation in plants with respect to BMR, cleaning records, all production related log books.

Operating and maintaining equipment Monitoring production processes Monitor production processes, identifying and reporting any issues Maintain accurate and complete records of production activities Ensuring adherence to quality standards and GMP Required Candidate profile Previous experience in API pharma manufacturing or a similar industry Ability to operate and maintain equipment Knowledge of GMP and other relevant regulations is essential

Knowledge of preparation of BMR, BPR, MFR, SMP, Change control, Deviation. Develop and implement quality assurance system Oversee quality control process Conduct internal audits & inspections Ensure laboratory compliance with regulatory requirements Required Candidate profile Bachelor's degree in a relevant scientific field like B.Pharma, M.Pharma, B.Sc Previous experience in quality assurance in laboratory setting or an API Mfg company Min 5 years of experience required

Hii, Greetings from Avaniconsulting ! We are hiring immediate joiners for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 5-10 yrs in API Notice Period - 1 month ( maximum) / immediate joiners Location - Mysore ( Nanjangud) Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical Salary- 20% to 30% hike on current ctc Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. if interested kindly share their updated resume with below details to priyanka@avaniconsulting.com or whatsapp to 9518220852 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Carry out the manufacturing operations according to the BPCR provided by QA department Perform the Operations in accordance to the established SOPs and cGMP. To maintain for Good documentation practice .To execute Production planning schedule. Required Candidate profile < Qualification : B.sc /M.sc(Chemistry)/B. Pharmacy/B. Tech ( Chem engg) - Any chemistry Background. < Having Pharma Experience of 2- 8 Years of experience. Perks and benefits Free Bus , Canteen, Pf

Manage all aspects of pharmaceutical production operations, including scheduling, resource allocation, and quality control, ensuring compliance with regulatory requirements. Develop and implement production plans to meet demand forecasts while optimizing efficiency and minimizing costs Organize, supervise and implement and achieve production targets in accordance with cGMP, safety and productivity Implementing cost saving measures to achieve substantial reduction in terms of raw materials, manpower and increased machine utilization Waste elimination in manufacturing system and Collaborate with cross functional teams, R&D, quality assurance, and supply chain, to drive continuous improvement initiatives and resolve production issues. Maintaining the Standards of Plant & Documentation with respect to regulatory expectations

Production Chemist required for a pharma company at kundli, sonipat Qualification- B. pharma Exp- min 7 yrs salary- upto 60k Wtsapp me resume at 8295842337- MR. Bansal

Sun Pharmaceutical Industries Ltd. Position: Senior Manager API Production (Block Head) Grade: G9B Location: API Ahmednagar - Production Planning and scheduling (day to day basis) - Ensuring resources available (BMR, Raw Material Manpower etc.) Liaison with QC/QA/STORE/Eng. Dept. for solving of trouble shooting problem. - Implementation and monitoring of GMP Standard. - Introduction and scale up of technology transfer. (New Prod 1ct) Constantly monitoring and improvement of product process, efficiency, services etc. - Documentation work, Monthly Report, data preparation (Process trend analysis) and root cause analysis. - Ensure the availability of consumable items & Planning of RM require as per campaign basis. - Ensure the documents related to process I cleaning / House Keeping. Control on fresh as well as recovered solvents/ spent solvent. - Ensure the solid and process waste transfer to respective area and record maintaining. - Other activities entrusted from time to time. Review the prepared/ Revision of BMR and SOP. - Operation of electronic system i.e.ONE HR portal, Metis Track wise, Minitab, Out Look etc. - Ensure Preventive Maintenance of Plant Equipment's in time frame. Ensure the training to subordinates. - Extended Facility of reactor Area of Plant-06 production Planning and scheduling (day to day basis)

Eligibility: Experience : 2-5 Years Position: Team Member Departments: API Production and SRS Qualification: M.Sc, Diploma, B.Sc, B.Tech Chemical Documents to Carry (Photocopies): Resume All Educational Certificates Previous Organizations Relieving Letters Current Offer / Increment Letter Last 3 Months Payslips Aadhar & PAN Card Must be willing to work in shift operations