234 Osd Jobs - Page 10

Role & responsibilities 1. Production Planning and Scheduling 2. Compliance and Documentation 3. Supervision of Manufacturing Processes 4. Personnel Management and Training 5. Quality and In-Process Control 7. Process Optimization and Yield Improvement 8. Regulatory and Customer Audits Preferred candidate profile Education: B.Pharm / M.Pharm / B.Sc with strong domain knowledge in OSD manufacturing. Experience: 15+ years in pharmaceutical production, with at least 5 years in a managerial role overseeing OSD manufacturing. Regulatory Exposure: Hands-on experience in facing WHO-GMP, and other inspections. Skills: Leadership, decision-making, analytical thinking, team management, and strong knowledge of GMP and QMS.

Role & responsibilities 1. Packaging Development activities for primary, secondary & tertiary packs for Domestic, Regulated & Non-Regulated market as per marketing/Regulatory/customer requirement. 2. Monitor & control the Artwork development and approvals. 3. Getting changes made in artworks from as per marketing, Regulatory & customer requirements. 4. Preparing Master Packing Specification, Material Specification & Approved Vendor List 5. New & Periodic Vendor Audits for packing material. 6. Shade approval & shade card management. 7. Interdepartmental & vendor co-ordination & follow ups. 8. Handling packing material complaints.

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

Role Summary: OSD Production QMS is responsible for ensuring adherence to quality standards within the production process. The role involves monitoring production activities, implementing quality control measures, maintaining compliance with regulatory requirements, and driving continuous improvement initiatives. Roles And Responsibilities Quality Compliance: Implement and monitor compliance with QMS standards Industry-specific standards. Conduct periodic audits of production processes to identify deviations and enforce corrective actions. Ensure all production processes align with regulatory and company quality standards. Documentation & Reporting: Maintain and update standard operating procedures (SOPs), work instructions, and quality records. Prepare detailed reports on quality performance, including non-conformance incidents and corrective actions taken. Process Improvement: Analyze production workflows and recommend improvements to enhance efficiency and quality. Participate in root cause analysis for production issues and implement preventive measures. Key Skills and Competencies: In-depth knowledge of Quality Management Systems and standards. Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities. Proficiency in using quality management tools and techniques. Familiarity with relevant USFD, EU, TGA regulatory requirements and industry best practices.

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.

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Roles and Responsibilities 1. Review of Technology data package and preparation of Gap analysis document. 2. Preparation of technology transfer protocol and report. 3. Co-ordination with FD for smooth Tech Transfer. 4. Monitoring of validation batches at production site. 5. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. 6. Review of MPCR and protocol. 7. Planning for Execution of Process design, Process qualification batch. 8. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. 9. Should be part of handling deviation, change control and failure investigations. 10. Process manufacturing parameters for Qualification batches Vs Commercial batches. 11. Preparation and reviewing of intended batch documents for regulatory submission. 12. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products.

Roles and Responsibilities Granulation: Operate and maintain granulation equipment (e.g., high shear mixers, fluid bed dryers). Perform wet and dry granulation processes, ensuring uniformity and consistency in batches. Monitor parameters like moisture content, particle size distribution, and granule flow properties. Compression: Operate tablet compression machines to produce solid dosage forms. Monitor compression parameters such as hardness, thickness, weight, and friability. Troubleshoot and adjust compression equipment to optimize production. Coating: Oversee the tablet and capsule coating processes, ensuring proper application of film coatings. Work with coating machines like pan coaters and fluid bed coaters. Monitor and control coating parameters such as spray rate, drying time, and temperature. Capsule Filling: Operate capsule filling machines to ensure accurate dosing of powder or pellets into capsules. Perform checks for capsule fill weight and ensure proper capsule sealing. Troubleshoot issues related to capsule filling, such as jammed capsules or weight discrepancies. General Responsibilities: Ensure all equipment is functioning properly and safely, adhering to preventive maintenance schedules. Maintain a clean and sterile environment in compliance with Good Manufacturing Practices (GMP). Perform in-process quality control checks to ensure that the products meet specifications. Document all activities, including batch records, machine logs, and quality checks in accordance with regulatory requirements. Collaborate with quality control and engineering teams to identify and resolve any production issues.onitor and control process parameters to ensure quality products meet specifications. Maintain accurate records of production data and perform routine maintenance tasks on equipment. Collaborate with team members to achieve daily targets and improve overall productivity. Ensure compliance with Good Manufacturing Practices (GMP) guidelines.

compliance with GMP and quality policie Approve RM/PM vendors and conduct regular quality audit validation, qualification, and batch release. GMP training $ support factory-wide implementation. Manage change control, deviation, and QMS execution.