3 Bcr Jobs

As an IPQA Specialist in an API manufacturing environment, your primary responsibility will be to monitor production activities and ensure cGMP compliance on the shop floor. You will be required to review and approve Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), and related analytical records before releasing API. Preparation and revision of SOPs, BMRs, BCRs, and other QA-related documents will also be part of your duties, aligning them with regulatory and internal requirements. Sampling of APIs, maintaining related records, overseeing proper cleaning and maintenance of sampling tools, and managing storage of control samples of API will be crucial tasks to uphold quality standards. Line clearance at each product changeover stage, coordinating dispatch processes, and supporting investigations of deviations and incidents with the QA Head/Designee are essential aspects of your role. Your involvement in Product Quality Reviews (PQR) for all APIs will require compiling relevant data and identifying areas for improvement. Monitoring process and cleaning validation activities on the shop floor to ensure compliance, supporting data integrity, documentation practices, and preparing for audits are integral to maintaining quality standards. Your collaboration with production, QC, engineering, and warehouse teams will be vital for addressing day-to-day IPQA requirements. Additionally, participation in risk assessments, change controls, CAPA implementation, and training QA executives and production personnel in cGMP, documentation, and in-process control requirements are part of your responsibilities. Handling quality events such as market complaints, recalls, and audit observations, contributing to continuous improvement initiatives, ensuring readiness and compliance for inspections and audits, and leading QMS enhancements and harmonization of documentation practices are key aspects of your role. Maintaining logs, registers, and master data related to IPQA activities, monitoring and reporting compliance KPIs to QA management, and representing QA in daily production meetings and batch release discussions are also part of your duties. **Qualifications:** **Education:** - Required: B.Sc in Organic Chemistry - Preferred: M.Sc in Organic Chemistry, B.Pharm / M.Pharm **Experience:** - 8 to 10 years of relevant experience in IPQA within an API manufacturing environment **Skills:** - Advanced knowledge in IPQA & Line Clearance Activities - Advanced expertise in Batch Documentation Review (BMR, BCR, BPR) - Intermediate to Advanced proficiency in Process & Cleaning Validation Oversight - Intermediate skills in Deviation/Incident Investigation - Intermediate understanding of Control Sample & Sampling Procedures - Advanced knowledge of cGMP & Data Integrity Compliance - Intermediate skills in QMS Documentation & SOP Preparation - Intermediate proficiency in Product Quality Review (PQR) - Advanced competence in Shop Floor Quality Monitoring - Intermediate to Advanced abilities in Cross-functional Communication & Coordination,

Job Objective : 1. Excellent team player/leader can efficiently motivate the subordinates to achieve the set targets within stipulated time. 2. Proficiency in written and oral communication skills. 3. Ensuring best in class quality and timely project execution 4. Strong initiative in decision making and owing up of responsibilities. 5. Strongly believe in turnaround of Business, systems and procedures with an integration of internal skill set along with outstanding team building. Job Role: 1. All activities related to production and monitoring the process as per SOPs. 2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons. 3. Check and implement the process for cleaning of equipment as per the schedules. 4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room. 5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports. 6. Responsible for preparation of daily production planning and ensuring the same. 7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets. 8. Ensure proper utilization of equipment and manpower as and when required 9. Planning and monitoring during execution of the process validation. 10. Manpower planning. Monitor the project modification activities. 11. Responsible to handle production processes as per BPR and cleaning as per BCR. 12. Responsible for reviewing of LFR/LDR, development report coordination with group leader, TSD, EHS & QA. 13. Responsible for reviewing the completed BPR’s in line with GMP guideline before handover to QA. 14. Responsible for responding the client review comment in BPR and others GMP related documents. 15. Allocating equipment to maintenance department as per preventive maintenance schedule. 16. Responsible to monitor all instruments such as temperature indicators, pressure gauges and their calibrations according to schedules. 17. Responsible to co-ordinate with QC for in- process/ intermediate /finished product sample results. 18. Conducting & participating the training programmes related to production operations, GMP and safety. Technical / Functional 1. Manufacturing-Production. 2. Compliance. 3. Validation. 4. Process scale up. 5. Technology Transfer. 6. Capacity enhancement. 7. PROCESS Safety management – Implementation 8. Cost reduction /Launching of new products. 9. Lean Manufacturing. 10. Expansion project.

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer questionnaire. Feedback giving to marketing related queries. Participate in customer and regulatory audits. Performing vendor/supplier audits. Performing Internal audits. Review of validation & Qualification documents. Preparation of Annual Product Quality Report & updating online trend analysis. Vendor Qualification activity. PR requisition in oracle. Verifying batch no. correctness in oracle before issuance of batch manufacturing records. GMP rounds. Retained documents management. All documents issuance, retrieval and review. Label, Seals procurement, Issuance, Control and Inventory Management. Day-to-day Coordination with all departments. Controlled Copies Issuance related to all departments. Preferred candidate profile Post Graduate in M.Sc with 6 to 8 years or relevant industry experience. Should be able to handle independently. Thorough knowledge of SOP preparation, validation and audits.