114 Bpr Jobs - Page 3

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

Job Description 1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements. 2) Execute and supervise all tasks and activities as per the applicable SOPs. 3) Complete self-training and monitor training of team members on the relevant SOPs. 4) Report any quality concerns or suggestions for improvements to Managers. 5) Review of Master document such as Validation protocol and reports. 6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint. 7) Ensure preparation and periodic review / updation of APQR. 8) Preparation & Review of Quality Assurance SOPs. 9) Review other Department SOPs. 10) Review of Executed BMR/BPR. 11) Participation in investigation of failures. 12) Participation in aseptic process simulation, cleaning validation and review of related documents and visual observations of Media fill vials. 13) In-process Quality Assurance during production activity and sampling at different stages of processing / packing as per requirement. 14) Monitoring and review of Quality system documents such as Deviation, Change control, OOS, OOT and CAPA. 15) Review of Master documents such as e-BPR, filter validation documents. 16) Review of stability study protocol and stability study reports Work Experience 5-6 years Education Graduation in Pharmacy Competencies

Responsibilities: This position requires experienced candidates with 4-7 years in Technology Transfer(Formulation). Co-ordinate for preparation of departmental SOPs/Guidelines/Operating instructions. To supervise transfer of batches from lab scale to Exhibit scale/commercial batches at the shop floor and to ensure quality system compliance. To prepare and review of Master Formula Card (MFC), Scale up protocol, Scale up BMR, process validation protocols (PVP), Stability protocols, Process validation report (PVR), Dissolution Profile Protocols (DPP) and Pilot Bio-Batches Documents. To assist in technology transfer of products from FR&D to production. Monitoring of lab scale batches for tech transfer products. Monitoring of Pilot Bio- Batches. Documentation of experiments online in LNBs. Co-coordinating with Cross functional departments i.e. PD, WH, QA, QC, AD, EG, & RA for process execution. Trouble shooting during commercial scale execution. To carry out feasibility trials in FR&D if required. Compilation of all executed batch process documents and analytical documents and assessing the impact on the commercial scale. Co-ordinate to prepare the specifications for raw material, packaging material, in-process, and finished product. Co-ordination with purchase/ sourcing department for procurement of materials. Co-ordination and participation of internal department audits/ sponsor or client audits. Co-ordinate to prepare Product development reports. To develop at least one skill in a year associated with the job. Note: Immediate Joiners are more Preferable

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance

Carry out manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control production parameters to meet quality and output targets. Ensure timely completion of batches to meet production schedules. Ensure adherence to current Good Manufacturing Practices (cGMP) and company policies. Report and document any deviations, incidents, or abnormalities during production. Operate, clean, and maintain manufacturing equipment (e.g., granulators, blenders, tablet compression machines, filling machines). Perform line clearance, changeovers, and cleaning as per SOPs. Maintain accurate and timely records of all production activities. Fill out logbooks, checklists, and BMRs/BPRs (Batch Production Records) as per regulatory standards. Coordinate with QA, QC, maintenance, and warehouse departments to ensure smooth workflow. Support validation activities, including equipment qualification and process validation.

Job Title: Team Leader - Packing (Solid Oral Dosage Forms) Location: Bangalore Department: Packing Reports To: Packing Head Job Summary: We are seeking a highly skilled and results-driven Packing Team Leader to oversee all packing activities related to Solid Oral Dosage Forms, including Blister Packing, Bottle Packing, Sachet Filling Line. The ideal candidate will be responsible for ensuring efficient packing operations that meet quality, quantity, cost, and compliance targets, while adhering strictly to safety and regulatory standards. Key Responsibilities: Lead and manage daily packing operations in Blister Packing, Bottle Packing to meet packing targets effectively and efficiently. Ensure smooth and reliable manufacturing processes through effective planning, resource estimation, and scheduling. Manage and oversee Quality Management System (QMS) activities, including Change Control, Deviations, Investigations, Risk Assessments, CAPA and Market Complaints. Collaborate closely with cross-functional teams such as Production, Quality, and Engineering to ensure seamless packing operations. Ensure strict adherence to Good Manufacturing Practices (GMP), safety protocols, and compliance standards. Qualifications: Bachelor’s/master’s degree in pharmacy. 10+ years of experience in pharmaceutical manufacturing, particularly in solid oral dosage forms. Strong knowledge of GMP, regulatory guidelines, and QMS. Proven leadership and team management capabilities. Excellent communication and problem-solving skill

Nutrizo Advancis Healthcare Private Limited is looking for IPQA-Chemist to join our dynamic team and embark on a rewarding career journey Conduct in-process quality checks during manufacturing Ensure compliance with GMP and SOP standards Document results and report deviations Coordinate with QA and production teams

Supervise day-to-day operations of Dry Powder Filling, Mixing, and Packing activities. Ensure batch manufacturing records (BMR) and other documentation are filled accurately and in a timely manner. Ensure cleanroom discipline and maintain the required environmental conditions in the production area. Coordinate with QA, QC, Maintenance, and Warehouse departments for uninterrupted production. Follow and enforce adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). Perform and supervise line clearance, cleaning, and sterilization procedures for equipment and areas. Maintain production logs, equipment usage logs, and cleaning records . Participate in investigations (deviations, incidents, and OOS) and implement corrective/preventive actions. Train new operators and assistants in processes and GMP standards. Monitor and report on yield, wastage, and productivity metrics. Ensure compliance with regulatory and safety requirements (USFDA, MHRA, WHO, EHS, etc.).

Operate and monitor compression machines (e.g., Cadmach - ACC). Ensure smooth execution of batch production as per BMR/BPR and SOPs. Carry out in-process checks (IPC) like weight variation, hardness, thickness, friability, etc. Perform machine changeovers, cleaning, and line clearance. Maintain and update Batch Manufacturing Records (BMRs), logbooks, equipment usage logs. Adhere strictly to cGMP, GDP, and safety norms. Participate in audits (internal/external) and handle compliance requirements. Collaborate with QA, maintenance, and validation teams. Report deviations, breakdowns, and implement corrective/preventive actions (CAPA). Suggest and implement process improvements for yield and productivity.

Execute daily coating production activities as per batch production records (BPRs). Supervise the mixing, blending, and application processes for various coating formulations. Ensure proper setup and maintenance of coating equipment (e.g., mixers, spray booths, curing ovens). Monitor in-process parameters and adjust formulations or processes to maintain product quality. Ensure compliance with ISO, GMP, and EHS guidelines. Coordinate with QC and R&D teams for sampling, trials, and product validation Maintain accurate production records, logs, and shift reports. Assist in preparing Standard Operating Procedures (SOPs) and work instructions. Report deviations, rejections, and ensure corrective actions are taken. Monitor raw material usage, stock levels, and report shortages. Ensure timely requisition and transfer of materials from the store to production.

Preparation of MFR, BMR and BPR. Preparation of batch manufacturing records, Batch packing record of all dosage forms.

Role & responsibilities Routine activities of Production department Batch processing CGMP GDP SOP Preferred candidate profile Relevant experience from Pharmaceutical and Chemical industry. Must have cGMP experience.

Role & responsibilities - Review of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and other related documentation. Implementation and monitoring of cGMP compliance across departments. Handling of deviations, CAPA, and change controls. In-process checks and line clearance during production activities. Conduct internal audits and support external regulatory audits (USFDA, EDQM, WHO, etc.). Review and preparation of SOPs and other quality documents. Training of personnel on GMP, GDP, and SOPs. Ensuring data integrity and documentation control. Preferred candidate profile 2 to 5 years of QA experience in An API manufacturing Unit Good communication and documentation Skill

Role & responsibilities Must have knowledge of dispensing of RM/PM. In-process quality checks Review BMR/BPR, regulatory books, online entries, sampling techniques. Calibration of IPQA instruments. Control sample and stability sample handling procedure. Preferred candidate profile Must have experience in OSD plant. Perks and benefits

Responsible for handling all activities pertaining to Tablets & Capsules & Pellets Mfg. Responsible to handle the team to achieve the set targets & maintain qualitative & quantitative as well as cGMP aspects. Perks and benefits Accommodation & Transportation And Mediclaim

Job Description: Operate, monitor, and optimize chemical production processes. Prepare chemical batches according to Standard Operating Procedures (SOPs). Ensure quality control through in-process testing. Coordinate with Quality Assurance (QA) and R&D teams for process improvement and new product trials. Maintain production documentation, including batch records, logbooks, and reports. Adhere to safety protocols, chemical handling procedures, and environmental regulations. Troubleshoot equipment malfunctions and process deviations. Support in scaling up lab-scale processes to full-scale production. Monitor inventory levels of raw materials and reagents. Train and guide plant operators and junior chemists. Apply knowledge of chemical plant operations, instrumentation, and safety standards. Ensure compliance with Good Manufacturing Practices (GMP), ISO standards, and relevant regulatory requirements. Key Skills & Competencies: Strong understanding of chemical processes and reactions Analytical and problem-solving skills Proficient in using lab and production equipment (e.g., reactors, mixers, dryers) Basic computer skills (MS Office, ERP systems) Effective communication and teamwork Required Qualifications: Education: B.Sc. / M.Sc. in Chemistry, Industrial Chemistry, Chemical Engineering, or a related field Experience: 15 years for entry to mid-level roles 5+ years for senior roles in chemical or pharmaceutical manufacturing Additional Information: At Avid Organics, we believe that we can achieve our mission to enhance value creation for our stakeholders only through the quality and commitment of our people. We continuously strive to unleash the potential of each individual. We leverage human capital for competitiveness by nurturing knowledge, entrepreneurship, and creativity. These strengths help us compete successfully in a global business environment and exploit emerging opportunities. We reward the will to succeed and the desire to compete with the best in the world. Our employees are intellectually stimulated and given the freedom to make their own decisions, driving our growth through innovation and experimentation. Apply Now! :- hr@avidorganics.net Visit our website or contact us at https://www.avidorganics.net Job Location: Survey No. 460/1,,,GEB SUB STATION ROAD,,POICHA-Ra nia, Ta.- Savli , VADODARA, Gujarat, India

Position : Assistant Manager- Production Location : Dahej Experience : 4-8 Years CTC Range : 5-9 LPA 1. Production Operations: Check and verify labels of raw materials, packing materials, and solvents before usage. Maintain appropriate storage conditions of raw materials and intermediates in the plant. Ensure adherence to process conditions during batch processing as per BMR (Batch Manufacturing Records). Take instructions from Shift In-charge / Managers for batch charging and monitoring. Report any deviations or discrepancies in plant/process to the Shift In-charge immediately. Complete assigned production tasks within the stipulated time. Maintain environmental conditions in the Production/Intermediate areas as per SOP. Perform reconciliation of accessories used in Production/Intermediate areas. Ensure zero contamination in the finished product. Perform packing and repacking activities as per operational requirements. Follow proper gowning and entry procedures in Production/Intermediate areas. Operate plant equipment and utilities as per operational SOPs. 2. Documentation: Complete online BPRs (Batch Processing Records), equipment usage records, and cleaning records accurately and timely. Maintain area pressure records, centrifuge bag records, and other documentation relevant to the Production area. Update equipment status boards and ensure the online completion of usage logs. Ensure proper labeling of fiber drums, hose pipes, and other batch-related tools. Ensure calibration of equipment such as weighing balances, pH meters, etc., as per SOP. 3. cGMP & Compliance: Guide and train workmen in the Finished Powder Processing section. Ensure the yield and quality of finished products meet predefined standards. Ensure packing of finished products is done as per SOP. Maintain cleanliness of the equipment and assigned production area. Participate in regular trainings to stay updated on cGMP, technical knowledge, and safety standards. Maintain and update personal training records regularly. Ensure reconciliation of intermediate products and cleaning materials. Remain aware of MSDS for all handled materials. 4. Safety, Health & Environment (EHS): Educate and supervise plant operators on safe chemical and equipment handling to prevent accidents. Coordinate with the EHS department for safety permits and compliance. Use scrubbers where required to prevent air pollution. Ensure no spillage of solvents and minimize material wastage. Shut off utility supply valves when not in use. 5. Interdepartmental Coordination: Coordinate with QC department for timely receipt of analysis reports. Coordinate with Engineering Services for any maintenance work required during the shift. Interested Candidate Please share your CV on Gmail- meet.chauchan@cadilapharma.com and also fill the detailes in the given link below: https://docs.google.com/forms/d/e/1FAIpQLScIYJJHOYg-KHEYPPmJXeN7e22-6-4spVE1BbsCG9E_XftzMQ/viewform?usp=header

Roles and Responsibilities Prepare and review batch manufacturing records (BMR) and batch processing documents to ensure compliance with regulatory requirements. Monitor production processes to identify areas for improvement and implement changes to optimize efficiency and productivity. Collaborate with cross-functional teams to resolve issues related to product quality, process optimization, and equipment maintenance. Ensure adherence to cGMP guidelines throughout the production cycle.

Job Description 1. Preparation of SOPs of QA, review of other departments' SOPs, 2. To perform batch release of API material and review of related documents. 3. To prepare and review Quality Risk Assessment, Site Master File, Hold Time Study Protocol/Reports, and other study protocols/reports, Specifications, Stability Protocol, and Stability Report Data. 4. Review of Validation Master Plan. 5. To review the analytical method transfer protocol/report and method validation documents of the API. 6. To ensure and handle the investigation of out-of-specification Results, OOT, Deviations, Product failures, and Market Complaints. 7. To review Quality system documents such as Deviation, Change control, CAPA, OOS, OOT, re-processing, Re-work, market complaints, and market returns. 8. To review Qualification Protocols/Reports of product, equipment, and facility. 9. To Review of the Annual Product Quality Review. 10. To review of Master Document, such as BPR, Test and Calibration Data Sheet, Test Procedures, and Microbiological Test Procedures. 11. To collect, review, and submit documents to the RA Department for dossier preparation /Regulatory Submission. Work Experience 5 to 8 Years Education Post Graduation in Chemistry Competencies

Role & responsibilities Job description Dosage forms experience: Solid Oral & Injectable experience in TTD/PDL/MS&T. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development in R&D and in Pilot/Manufacturing Site. Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments. Dedicate Experience in technology transfer of product(s) under development activities from scale up, exhibit batches. To lead and support the site transfer products from scale up to product launch. To prepare, review and hand-over the Technology Transfer Dossier to plant and communicating effectively to CFT team :- MFR, MPR, BMR, BPR, Preliminary Risk assessment (as per QbD) Risk Assessment of before going to Scaleup Risk Assessment of before going to Exhibit batches Scaleup Protocol & reports Scaleup Sampling and Exhibit batch sampling Plan Exhibit batch reports Control Strategy (Qbd) before Scaleup, Exhibit batches Risk assessment of CPP over CQAs and etc. And not limited to. To provide the technical inputs for initiation of Scale up batches. To provide the technical presentation on new product initiation to Cross functional team. To monitoring and execution of Scale up batches for site transfer products as well as in-house developed products. To co-ordinate with cross functional teams for smooth technology transfer. To review the exhibit batch documents, intended documents for filing purpose. Qualifications M.Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in technology transfer solid oral formulations and injectable products.

Handle BMR and batch repacking records, Verify daily balance checks and calibration activities, Maintain production records, Perform and verify line clearance at manufacturing and packing stages, Issue and retrieve production documents Required Candidate profile Graduate candidates with 2-5 Year experience and knowledge about cGMP Practice, QMS tools knowledge, Production and Manufacturing documentation process. We are looking for local candidates ONLY.