138 Bpr Review Jobs

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications

Responsibilities: Responsible for creating, maintaining, managing accurate & compliant production-related documentation. This role ensures that all documentation adheres to internal standards and external regulatory requirements.

Maintaining good housekeeping and cGMP in shop floor Preparation of New documents like BPCR and SOP Deviation , change control, OOS, activity and is compliance Plant keeps ready for audit Overall responsibility of cGMP Production should be achieved as per target. Equipment cleaning Log book and Solvent log Book to be maintained. BPCR arrangements for running batches. Review and completion of all documents like BPCR, Equipment logbook, and format as per SOP

Conduct quality inspections and tests on raw materials, in-process production, and finished products.Monitor and document quality control processes and compliance with quality standards.Identify defects or deviations

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

Conduct regular inspections and audits of products, processes, and systems.Identify quality issues and implement corrective actions.Develop and maintain quality documentation, including SOPs and checklists.

Develop, implement, and maintain QA policies, procedures, and documentation. Conduct internal audits and assist with external audits (e.g., ISO, FDA, etc.)

Division Department Sub Department 1 Job Purpose Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation. Key Accountabilities (1/6) Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations Perform calibration, clean and set different equipment and machines as per SOP and schedules for on-time completion of batch processing Check the suitable change part as per product requirement Arrange change parts & stereo for batch packing activity Key Accountabilities (2/6) Operate the packing machines by using minimum resources to get quality product Evaluate the product dimensions and set the machine for changeovers Perform in-process checks in packing machines to ensure proper functioning of machine Perform labelling and handle rejection control in packing machine Reduce micro stoppages and avoid non-conformances during packing machine operations, cleaning and line clearance Maintain equipment, facility and block premises as per SOP for audit readiness and to avoid critical and major observation Perform all operations as per cGMP and safety to reduce rejection Key Accountabilities (3/6) Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP. Fill Machine logs & other relevant documents precisely to meet cGMP requirements Check documentation before submission to ensure data integrity Conduct training related to cGMP, equipment operation, for workmen to minimize deviation from procedure Provide technical support to operators about packing activity and cGMP to get quality output for any up-gradation during packing activity Key Accountabilities (4/6) Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety Perform regular interlock checks of packing machines and perform safe operations Ensure usage and maintenance of PPEs by workmen during shifts Report any near-miss to officer in-charge in time Key Accountabilities (5/6) Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations Provide training to other operators about secondary packing machine settings and operations Conduct training related to safety and housekeeping for workmen Participate in learning of new machine and build expertise in troubleshooting the machines Key Accountabilities (6/6) Major Challenges Meeting shift target due to unavailability of adequate resources. Overcome by efficient work load distribution Maintaining cGMP requirements during system downtime. Overcome by coordinating with engineering and technical support team Low yield due to more rejections. Overcome by controlling rejection and simplification of process and attending training Key Interactions (1/2) Store for daily dispensing plan and availability of packing materials (Daily basis) Engineering for preventive maintenance and help in modification (as per need) Key Interactions (2/2) Maintenance contractor for any machine repairs (Need Based) Dimensions (1/2) Achieve average volume of 60 mn (FY2015-16) Average number of BPR’s handled : 60 Average number of batches in packing : 60 Average number of sales order dispatched : 25 Achieve internal OTIF more than 90% Achieve Zero reportable accidents/ incidences during packing activities Achieve 0% errors in online documentation Meet 100% compliance to SOP and Safety regulation Dimensions (2/2) Key Decisions (1/2) Up-gradation in facility and documents to Section Head - Packing Modification in equipment to Section Head - Packing Deviation and implementation of CAPAs Section Head - Packing Key Decisions (2/2) Education Qualification Diploma (Engineering / Pharmacy) Relevant Work Experience 0-2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents

Role & responsibilities Execute daily production operations and ensure the efficient functioning of the department. Supervise and monitor manufacturing processes to ensure compliance with quality standards. Review and maintain production-related QMS elements, including Change Control, Deviation, Event Investigation, and Corrective and Preventive Actions (CAPA). Prepare and review Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packing Records (BPRs). Address and resolve production issues promptly to minimize downtime and ensure continuous production. Respond to challenges or bottlenecks and implement mitigation strategies within defined timelines. Ensure that all processes and documentation comply with SOPs and protocols. Maintain and review all production-related records, including batch records, equipment logs, and production output reports. Prepare regular reports on production output, efficiency, and quality metrics for management review. Coordinate with the maintenance department to resolve equipment breakdowns and ensure smooth production activities. Oversee the document control system to ensure the availability and integrity of quality documents. Preferred candidate profile Bachelor's or Masters degree in Pharmacy, Life Sciences, Biotechnology, or a related field. Minimum of 1 year of experience in a production/QMS-related role within the pharmaceutical, biotechnology, or manufacturing industry. Strong understanding of QMS principles, regulatory compliance, and production processes. Ability to analyze and resolve production-related challenges effectively. Proficiency in documentation, report preparation, and adherence to SOPs.

QA Executive For Agro chemical Industry In Saykha,Bharuch, Gujarat Job Title: Executive/Sr Executive Department: QA Experience Required: 5 to 10 years

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications

Conduct inspections and audits of products, processes, and documentation to ensure compliance with quality standards. Review and verify that procedures, specifications, and regulations are followed.

Job Description 1. Preparation and review of operational packing materials list, Packaging materials specifications, Packaging materials specifications base documents, BOM, BPR (PAS X and SAP), In House Labels for Exhibit Batches, Pack Split Up and Pallet Matrix. 2. To provided technical support to Production, QA, QC and RA. 3. Review of Artwork, Shade cards and print proof etc. Initiate Change controls, Deviation and CAPA and close all action item of change control, CAPA and deviation within time frame preparation of investigation report of deviation. Coordinate with R&D and QA for Primary Packaging Materials Specifications, Primary Pack Specification and Standard Test Procedures. 4. Preparation and Review of SOP’s, Protocols and Reports. Supervise compliance to all cGMP or any other regulatory requirements, including EH&S requirements. Execute and supervise all tasks and activities as per applicable SOP’s. Work Experience 2-4 years Education Graduation in Pharmacy Diploma in Packaging Technology Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Role & responsibilities Responsible for all in process Quality Assurance Activities Document issuance and control Preparation and review of SOPs, Protocols, Reports, BMR, BPR and QC Specifications Issuance and review of BMR and BPR and other quality system documents Internal audit and its compliance related activity Ensuring compliance to cGMP Prepare Annual Training Plan in co-ordination with Head of QA Schedule and coordinate the cGMP training session Assist in the delivery of new employee orientation training Assure training records are maintained for regular, temporary and contractors/consultants Check monthly log book and calibration of IPQA instrument and balance Stability and control sample management Preferred candidate profile Should be worked in QA Department Well versed with computers, MS officer knowledge is must. documentation skills required

Job Description Join Lupin Limited's dynamic Quality division as an Officer within our Validation department based in Pithampur. In this pivotal role, you will take charge of the cleaning validation activities for our API and Formulation facilities. Your responsibilities will encompass comprehensive management and execution of validation protocols supporting our commitment to the highest quality manufacturing standards. Your core duties will include ensuring rigorous residue cleaning validation processes to maintain contamination-free production environments. You will manage and evaluate nitrosamine and genotoxic cleaning validation activities, essential to safeguarding product safety and regulatory compliance. In addition, you will perform risk priority number (RPN) calculations to identify and mitigate potential risks effectively. Campaign studies including CEHT/DEHT will fall within your scope, enabling process optimization and validation integrity. The role extends to qualification activities for facilities, equipment, utilities, and HVAC systems, ensuring all operate at validated standards aligned with industry and regulatory requirements. As the Officer, you will prepare and review validation-related documentation with precision, supporting audit readiness and continuous improvement initiatives. Your efforts will directly contribute to Lupin's mission of delivering safe, efficacious pharmaceutical products to global markets. We seek an individual with a keen eye for detail, exceptional organizational skills, and the ability to collaborate cross-functionally. Your proactive approach to validation and quality processes will drive success and uphold our high standards. At Lupin Limited, you will be part of a culture that values innovation, strategic thinking, and continuous development. Join us to advance your career in a challenging and rewarding environment where your expertise makes a meaningful difference. Work Experience Applicants should have between 2 to 5 years of relevant experience in pharmaceutical cleaning validation or quality assurance sectors. Experience in executing and managing cleaning validation protocols, facility and equipment qualification, as well as working knowledge of regulatory requirements related to pharmaceutical manufacturing, will be highly valued. Education Graduation in Pharmacy Competencies Strategic Agility Innovation & Creativity Customer Centricity Developing Talent Result Orientation Process Excellence Collaboration Stakeholder Management

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

IPQA, IPQA Officer, IPQA Chemist ,GPM,BMR SOP, Pharma Process, FDA Approval, COsmetic Healthcare Industry, Direct Call:9974756637 whatsapp Resume:9974756637

Line Clearance for Dispensing, Manufacturing & Packing activities Dispensing of RM/PM for batch Mfg Monitoring of IPQA activities (Granulation, Blending, Capsulation, Compression, Coating, Packing Sampling of IP and FP Samples Batch documents review

Working Hours - 8 Hrs Role & responsibilities Dispensing, Manufacturing, Packaging and Dispatch activities. -Review and control of SOPs, BPR Issuance,Cleaning Validation,Line Clearance. -Master Formulae and records. -Good Documentation as per GLP,Preparation. -Review of process validation protocols and reports. -Familiar with Production machinery, Production floor working, pH meter, Refractometer, and GLP.

Execute day-to-day production activities as per production plan. Operate and monitor production equipment (Granulation, Compression, Coating, Packing, etc. based on plant). Ensure adherence to cGMP, SOPs, and regulatory guidelines during all production activities. Maintain batch manufacturing records (BMRs), logbooks, and online documentation. Coordinate with QA, QC, Maintenance, and Warehouse for smooth operations. Implement safety, quality, and housekeeping standards within the production area. Support investigations (deviations, OOS, incidents) and assist in CAPA implementation. Train new operators / apprentices on processes and equipment. Participate in qualification/validation activities of equipment and area.

Ensure accurate and timely processing of invoices and monitor incoming payments. Manage and oversee the daily operations of the AR department including invoice processing, payment processing, and account reconciliation. Knowledge of TDS & GST. Secure revenue by verifying and posting receipts and resolving any discrepancies. Maintain accurate records and control reports for all AR transactions. Use accounting software and MS Excel to process business transactions and compile reports. Collaborate with other departments to ensure billing accuracy. Address and respond to customer inquiries regarding invoices and payments. Ensure compliance with accounting principles and company procedures. Participate in financial audits and implement audit recommendations. Contribute to team efforts by accomplishing related results as needed. Drive operational excellence and continuous improvement in the AR process. Handle refund processes efficiently and effectively. Demonstrate a global mindset and entrepreneurial spirit in all tasks and projects. Foster a culture of people excellence within the team. The candidate should have a strong financial and commercial acumen, with a deep understanding of accounting principles and proficiency in accounting software. The candidate should also have excellent problem-solving skills, be a team player, and have a strong focus on customer service.

As an Assistant Manager in the Contracts_WMEL team, you will be responsible for managing and overseeing all aspects of contract administration within the organization. This includes but is not limited to drafting, reviewing, and negotiating contracts, ensuring compliance with labor laws and statutory requirements, and managing relationships with stakeholders. You will also be responsible for preparing and maintaining all necessary documentation and reports related to contracts.

Skill Required Roles and Responsibilites 1. Media fill and qualification summary preparation knowledge. 2. To maintain track of qualification and validation activities. 3. To prepare and review the protocols and reports. Execution of various qualification / validation activities. 4. To review correctness of the technical documents received from the supplier (DQ/OQ/IQ/PQ,FAT). 5. Co-ordinate with production and other user department for qualification/validation activities 6. Timely compile and review of qualification validation reports. 7. To review the equipment documents like calibration reports and ensure correctness of documents. 8. To perform FAT. 9. To co-ordinate with outside agencies for execution of qualification activity whenever required. 10. Identification of deviation through review and observation. 11. To prepare annual Re-qualification/validation schedule, update VMP and Qualification related SOPs as and when required. Qualification Required B. Pharm/ M. Pharm/ MSC. Relevant skills / Industry experience 2 to 3 years experience in USFDA, MHRA, TGA approved plant

Purpose of Job 1. Preparation and Review of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Having basic knowledge on Microsoft Word and Microsoft Excell 2. Have knowledge of Minitab software for statstical evaluation of data. Roles and Responsibilites 1. Preparation and review of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Qualification Required B. Pharm or M.Sc. Relevant skills / Industry experience 1. Should have relevant experience in Regulatory approved plant.

Purpose of Job 1. Preparation of PQR. 2. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. Skill Required 1. Utilization of Microsoft Word and Microsoft Excell 2. Using of Minitab software for statstical evaluation. Roles and Responsibilites 1. Preparation of PQR schedule. 2. Planining of PQR compilation as per PQR schedule. 3. Collection of data from all the CFT teams for compilation of PQR. 4. Statistical evaluation of identiifed CPP & CQA at Manufactuirng and Quality Control stage using Minitab software. 5. Based of the PQR data recommendation to be recommended to concern department and ensure implemenation of the same. Qualification Required B. Pharm or M.Sc. Relevant skills / Industry experience 1. Should have relevant experience in Regulatory approved plant.