155 Batch Manufacturing Jobs - Page 7

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Role & responsibilities Conduct in-process checks during various stages of sterile injectable manufacturing, including dispensing, compounding, filtration, filling, and sealing. Perform line clearance and area clearance before the start of manufacturing and packaging operations. Monitor aseptic practices and personnel hygiene compliance inside cleanrooms and controlled areas. Verify critical process parameters and environmental conditions during batch processing. Ensure compliance with SOPs, batch manufacturing records (BMR), and batch packaging records (BPR). Participate in visual inspection activities and oversee container-closure integrity checks. Monitor the usage and replacement of sterilized garments, materials, and equipment in aseptic areas. Raise deviations, non-conformances, and change controls as needed. Assist in investigations for OOS, OOT, or any batch-related quality issues. Provide training to operators and workers on GMP, GDP, and aseptic technique

Key Responsibilities: Operate, monitor, and maintain Lyophilizers, HVAC systems, chillers, and AHUs to ensure efficient functioning. Perform routine and emergency maintenance tasks, ensuring minimal downtime and optimal performance of equipment. Maintain accurate operational records and detailed maintenance logs for all equipment. Ensure adherence to cGMP (current Good Manufacturing Practices) and cleanroom standards in daily operations. Follow Quality Management System (QMS) protocols, including SOPs (Standard Operating Procedures), change control, and Corrective and Preventive Actions (CAPA). Troubleshoot equipment issues and implement effective solutions to prevent recurrence. Conduct equipment qualification and requalification processes to ensure compliance with regulatory requirements. Collaborate closely with cross-functional teams and leadership to meet production and operational goals. Job Location: Bus transportation facility available from Ahmedabad, Kalol & Kadi. Education Qualification: I.T.I Fitter

Position : Section Head - Batch Release QA Functional Area: QA Reports to: QA Head Grade: G9B Department: Quality Location: Halol (OSD) POSITION SUMMARY Responsible for IPQA activity and strategy in line with Sun Pharma Compliance, Product Quality Management objectives and Regulatory requirements. Responsible for planning and arranging for internal and external departmental support of quality assurance activities as directed in approved protocols, quality systems or Procedures. Identify and implement solution for improving existing site quality assurance systems and processes Involvement in co-ordination of activities for software like SAP HANA at plant Responsible for review and Approval of Quality management/GMP records. Responsible to ensure and perform site data review of batch records for completeness of documentation, approval and rejection of materials per current good manufacturing procedures and escalation of quality incidences, Continuous process verification (CPV). Manage the batch release function at site wrt documentation, systems, approval and rejection of materials, products at the Site per current Good Manufacturing Practices requirements. The incumbent will assure individual compliance with the all concerned regulatory requirements, GxPs and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures. Key responsibilities: 1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures. 2. Manage Batch release activities for commercial dispatch. 3. Escalate compliance concern to concern stakeholder. 4. Review, compliance of BPR and batch release for commercial dispatch. 5. Review and approve the investigations, CAPA, and effectiveness checks with adherence to timeline. 6. Execute change control and risk assessment whenever required. 7. Ensure Quality Metrics, Quarterly BPR report as per specify timeline. 8. Ensure timely Batch release through electronic system. 9. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures. 10. Follow the EHS policy and maintain the compliance to GMP requirements. 11.Co-ordination with QPs and customers of different region for batch release. 12.Management of Technical agreement with QP and Customers. 13.Responsible for oversight in warehouse and BSR. 14.Management of retain sample storage , inspection and life cycle management. MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS M.sc / M. Pharm/ B. Pharm 15 years with work experience preferred. REQUIRED SUCCESS ATTRIBUTE Knowledge of GxPs, cGMP and other regulatory requirements. Planning and Prioritization Collaboration Accountability Compliance Customer Service orientation Secondary Success Attributes People Connect Attention to detail Emotional control Effective Communication & Problem solving WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Role & responsibilities We are looking for candidate on below criteria at our Nalagarh Plant Himachal Pradesh location. Candidate must have completed Pharma, M.Sc. or B.Sc. in Chemistry. Experience of regulatory industry would be preferred. Candidate should have 1-3 years of working experience Preferred candidate profile Responsible for Line clearance in Warehouse and Production area during dispensing, MFG, Filling and Packing & review of log books and status label of each equipments before start of activity. Responsible to carry out in-process checks as per respective Batch Production Record in Manufacturing, packing and warehouse. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. Responsible for collection of in-process samples, FP sample, control samples, validation & stability samples. Responsible to make SAP entries, Release of inspection lot of SFG & FG, Physical sampling confirmation, Approval of Batch Production Records for printing and additional page issuance. Responsible for online review of Batch Production record and make entry of data required for trending in maintained excel sheet for preparation of APQR. Responsible for Line clearance in Warehouse and Production area during dispensing, MFG, Filling and Packing & review of log books and status label of each equipment’s before start of activity. Responsible to carry out in-process checks as per respective Batch Production Record in Manufacturing, packing and warehouse. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. Responsible for collection of in-process samples, FP sample, control samples, validation & stability samples. Responsible to make SAP entries, Release of inspection lot of SFG & FG, Physical sampling confirmation, Approval of Batch Production Records for printing and additional page issuance. Responsible for online review of Batch Production record and make entry of data required for trending in maintained excel sheet for preparation of APQR. Perks and benefits