159 Bpr Jobs - Page 7

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 & 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

PRINCIPAL ACCOUNTABILITIES: - BPR Planning and review Scan the organizational processes, identify gaps at granular level and generate ideas for themes aligned with organizational vision and objectives to be put up to management for AOP and LRP discussions. Lead sessions with business stakeholders to understand business processes, business requirements, business rules, data and systems to formulate business solutions. Identify and analyze business problems and defines the scope of activities required to address the issues, including requirement definition, process review, impact assessment and operational streamlining where appropriate. Creation of Business Process Reengineering (BPR) strategy Project Management Lead & review project plans, identify and align key project stakeholders, undertake resource identification and allocation across functions for the projects. Data Analysis & Review Analyze the data from the current process where available else set a measurement system to gather data form the process; Review the data gathering process undertaken by the team. Process Mapping & Benchmarking Analyze the as-is process; Evaluate and understand the system implications and requirements; benchmark process with the industry and conduct extensive analysis. Generate ideas, propose alternatives for solution along with other functional/ business stakeholders to drive process efficiency and effectiveness; Put up to the stakeholders to seek approval. Determine approach for implementation of the solution and seek involvement from relevant stakeholders such as IT, function teams, etc. for the process change. Monitor the change post implementation to ensure change is stabilized and benefits are accrued. Review the benefits agreed on and delivered post implementation and provide BPR sign off and put up the functional team for sign off. Stakeholder Management: Collaborate & align with stakeholders & cross functional team to create & implement the best practices in reengineering projects. Team Management Participate in selection process to identify the right talent for the team and prepare succession plans Motivate, engage and retain key talent in the team Establish individual performance expectations and evaluation metrics, and regularly review individual performance Identify and create development opportunities for team members to enhance functional knowledge Guide the team to execute projects until closure across the various stages of the projects Resolve escalated issues faced by the team and remove roadblocks to ensure smooth execution of projects

Job Description Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments. Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches. Review of executed BMR/BPR of commercial and exhibit batches for batch release. Issuance, Retrieval & Destruction of SOP’s, STP, specification, BMR/BPR, annexures & other formats. Login and review of quality system documents such as Deviation and IPOOS. In-process Quality Assurance during Production / Packing activities. Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.) Review of qualification / validation documents, stability data and Executed documents. Participation in investigation of failures and release of batches. Shop floor monitoring and ensuring the compliance as per designed procedures. Preparation, review and tracking of hold time protocols / reports Work Experience 5 to 8 year Education Graduation in Pharmacy or Pharmacy Competencies

Opening for Pharma company Location : Mahemdabad Role & responsibilities : Continuous process Monitoring Batch Release of Finished product Collection of Sample ie in-process, Finished Product , Control, Stability and Tendor Knowledge of Collection of Validation samples i.e process validation, cleaning and hold time validation. Knowledge of review of Master and executed MFR/BMR and MPR/BPR Adequate knowledge of Inprocess checks of Tablet ,Capsule ,Liquid and Ointment. Adequate knowledge of Shop floor related Non-compliance ,its root cause and compliance. Adequate knowledge of calibration of instruments ie weighing balance , friabilator, DT apparatus, hardness tester, Vernier calliper, Moisture analyzer, leak test apparatus and Ph meter etc. Interested candidates shared resume on snehal@topgearconsultants.com

Position: Production Chemist Job Location: Jammu (Samba) Industry Preference: Candidates with API Plant Interview Mode: Face-to-Face (Walk-in Interview) Interview Location: Chandigarh interested candidate share resume on 9815675900

- Sterile Injectable Manufacturing (Core) - Liquid ampoules, vials, lyophilized products - BMR/BPR Documentation - cGMP - Production Line Operation - Pharmaceutical Equipment Handling - Cleaning/Sterilization - Internal Audit/Validation - Maintenance

- 8+ yrs in Sterile Injectable Manufacturing - 3+ yrs as Production Manager in Injectable Plant - Handling Liquid Ampoule, Vial, and Lyophilized Vial Lines, BMR/BPR Documentation - Leadership & People Management - cGMP; WHO-GMP; FDA Guidelines, SOP

1.To Initiation , review and conduct Calibration of IPQA Instruments. 2.To review all usage logs of Manufacturing and Packing Area. 3.To review and follow up for Annual Maintenance Activity of IPQA Instruments. 4.To fill and review IPQA instruments log books. 5.To review and provide Line Clearance for Manufacturing Equipments / Packing Equipments.