65 Bpr Jobs - Page 3

collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications. Ensure that all necessary documentation is completed accurately Call: 91-9327657730 / 9724346949 Required Candidate profile Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing. Preparation & review (MOA), standard testing procedure (STP) and other documents related to QC.

Hii, Greetings from Avaniconsulting ! We are hiring for Production associate for a leading Pharma API Manufacturing company Position- Associate Work Experience Min 3-8 yrs in API Location - Mysore ( Nanjangud) Gender - Any Qualification- B.Tech in Chemical Engineering /Msc Chemistry/Diploma Chemical Salary- 20% to 25% hike on current ctc Roles & Responsibility 1. Responsible for appropriate production planning & execution of batches in line with targeted commitments complying cGMP& Safety requirements. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by team while in the department. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and respective departmental procedures. 4. To ensure good housekeeping in the production shop floor. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the product of intended Quality. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to QA for review, compliance & release / rejection. 7. To report deviations / incidents immediately upon occurrence and to conduct investigation in coordination with cross functional teams. 8. To ensure all document entries are performed online with legible, errors corrected with signature and date. 9. Monitoring and control of manufacturing environment and filling of daily log books. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments are performed as per schedule & the outcome of verification is within control. 11. To ensure the sanitization activity is performed in the department. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents, complaints or recalls, validations and any other support that would be required. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of process and stored with appropriate segregation at recommended storage conditions ensuring no impact on product Quality. 14. To ensure that stocks are reconciled at regular intervals. 15. Any other assignment allocated by Production head. if intrested kindly share their updated resume with below details to mona@avaniconsulting.com or whatsapp to 7327039030 1. Current CTC: 2. Expected CTC: 3 . Notice Period: 4. Total Experience 5. Current Location: 6. Preferred Location: 7. Reason for change:

Role & responsibilities B. Tech OR B.E. chemical engineer. 4 to 6 years& experience in API/ CHEMICAL/Bulk drug process and technology transfer & outsource activity. Work and collaborate with chemistry teams in the labs and pilot plant and design and execution of experiments to ensure robust trouble-free processes are developed. Also to engage in tech transfer activities. Also create technical content as apart of technology transfer activities like tech transfer document, PIDS, BPR, PFD etc. Ready to work in rotational shift. Preferred candidate profile R & D and technology Transfer R & D and technology B.Tech. Chemical or B.E. Chemical 3 to 6 years. Perks and benefits Negotiable

RESPONSIBILITIES Preparation and review of master batch records / batch manufacturing records, qualification documents (URS, DQ, IQ, OQ, PQ, volumetric calibration, surface area calculation etc.) & QMS documents. Preparation and review of standard operating procedure. Preparation and review of organogram, job responsibility, training needs & list of list. Preparation and review of training matrix & training plan. To ensure online documentation related to all CGMP activities including data integrity. Initiate, review & complete required change control, deviations, investigations & CAPA impact. Reviewing & maintaining all logbooks in the manufacturing area and plant. Operation of primary and secondary water treatment plant as per standard operating procedure and look after operations in solvent recovery plant. Responsible for performing validation & qualification activities in the plant (equipment qualification, process validation, cleaning validation). Responsible for the execution of validation & scale up batches for all the products to be manufactured. Proper utilization of available manpower (no contract people) & manufacturing facilities to enhance productivity. Ensuring timely manufacturing schedule as per production planning & maintaining quality & safety parameters. DESIRED SKILLS Must have experience in API production in reputed pharma organizations. Should have hands on experience of Manpower Handling Strong knowledge of operating DCS (Distributed Control System) One Should Manage Shift Planning Handling of Water System Operation Handling of Process Equipments like Reactor, Centrifuge, RCVD, RVPD, FBD, Bin Blender, Co-mill, etc Good Knowledge of preparing BMR and BPR. Should have sound knowledge of drafting and reviewing of SOP’s. Good Communication and problem solving skills. Should be assertive, proactive, and self-driven. Ability to work in dynamic environment.

- Experience of Calcium Lactobionate Manufacturing - Responsible for preparing work instruction for Production and manufacturing activities - Maintain online documentation related to production activities like BMR, BPRs, logbooks and daily records. Required Candidate profile Relocation from Maharashtra only - Qualification of production equipment and participation in validation activities - Maintaining documentation such URS, DQ, IQ, OQ, PQ validation protocol with report

Role & responsibilities Relevant Experience : Should have experience of Production for Formulation Plant of Oral Solids (Tablets, granules, powder) & Allied in PHARMACEUTICAL COMPANY / FACTORY. FDA Approval in Tablet Section Pharma Formulation plant would be preferred. 1. Batch Manufacturing Manufacture production batches as per Batch Manufacturing Record (BMR) and Batch Production Record (BPR). 2. BMR/BPR Documentation Complete the online BMR and BPR as per the respective activities. 3. Coordination with QA Coordinate with the Quality Assurance (QA) department for the issuance of monthly formats. 4. Manufacturing Parameters Review Review parameters during manufacturing stages such as compression, filling, and packing for oral dosage products. 5. SOPs and Documentation Prepare, update, and maintain Standard Operating Procedures (SOPs), BMR, and BPR documents. 6. Document Maintenance Ensure proper maintenance of documents, including BMR, BPR, cleaning records, calibration logs, environmental records, and equipment usage logbooks. 7. Manpower Allocation Allocate and manage manpower for the effective utilization of resources. 8. Production and Packing Oversight Oversee and manage the overall manufacturing and packing activities in the oral department. 9. Compliance with cGMP & GDP Monitor and implement Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) within the department. 10. Quality Management System: Handle the Quality Management System (QMS), including initiating, investigating, and completing change control, deviations, and incidents. 11. Equipment & Area Qualification: Monitor and review equipment and area qualification activities and ensure timely reporting. 12. Validation Activities Coordinate with QA and QC departments for product process validation and cleaning validation activities. 13. Production Target Achievement Ensure daily and monthly production output targets are achieved. 14. Cross-Department Coordination Facilitate coordination between Quality Assurance, Quality Control, Warehouse, and Engineering departments. 15. Material Availability Check Ensure availability of required raw materials (RM) and packaging materials (PM) as per the production plan and schedule. 16. Training & Development Conduct training programs on SOPs, GMP, technical procedures, and identify training needs for department personnel. 17. BMR/BPR Handover to QA Ensure completed BMR and BPR are handed over to the QA department before dispatch activities. Required Candidate profile: 1. 07-10 years of experience in Formulation Pharmaceutical Plant. 2. Relevant Experience in Pharma formulation plant. 3. Computer proficiency in MS Office, Excel, e-mail and internet functions, ERP

To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers. To review the process validation/ cleaning validation qualification protocols. To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety Quality management system. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety standards (FSS) act and other legal, customer and regulatory requirements. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits. To ensure compliance to the current ISO 9001, DC Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility. To ensure completion of APRs of products and take appropriate actions in case of deviations. Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively. To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals. Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 111. Ensuring avoidance of breach of data integrity at all the levels. Ensuring implementation of effective sanitation activities at all the levels. Imparting required training to shop floor personnel. Adherence to the requirements of EHS norms. To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items. To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA. To perform MSC2N transactions in SAP. Review of Change Control, Deviation, CAPA in trackwise. Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset). SOP, BMR/BPR, layouts, STP review and approval in ENSUR system. To conduct vendor audits for RM/PM. To lead and guide the IPQA team for shopfloor activities. To set, review and evaluate KRA of reportee s. To share the RR nominations of team members on quarterly basis. To identify and implement the OE projects. Patient/ Customer centricity. B. Pharm/ M. Pharm

In-Process Quality Assurance During Production Activity Including Line Clearance And Sampling At Different Stages Of Processing/Packing As Per Pharma API Review of Master Documents such As BMR / BPR Test Batch Monitoring Process Validation Protocol Required Candidate profile Experience with reputed API or Bulk Drugs Unit Co-Ordinate with Plant QA And RA for PDR related activities To Review Specification, MOA And Analytical Data Good Computer And Communication skill Etc

1. Maintain on-line documentation to meet GMP requirements. 2. Proper planning of shifts and workmen in mfg. dept. to meet the schedule. 3. To ensure all operations in mfg. are as per SOP. 3. Online submission of samples & maintains records.

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

To prepare and review Validation Master Plan (QMP, VMP, PVMP, CVMP and CSVMP). To follow the validation master plan.To prepare and review qualification and validation documents and execution as per protocol. Required Candidate profile Preparation&review of URS,FS,DS,DQ,RA,IQ, OQ&PQ & summary reports for Equipment, System&Utilities.Handling & storage of all quality document like BMR,BPR,log book, protocol & SOP throughout life cycle

To prepare & review Validation Master Plan(VMP), Qualification Master Plan (QMP) & Computer System Validation Master Plan(CSVMP) To follow the validation master plan To prepare & review Qualification & Validation Documents & execution as per protocol Required Candidate profile To update equipment & utility periodic requalification/re-verification schedules on monthly basis.Handling & storage of all quality document like BMR, BPR, log book,Protocol&SOP throughout life cycle.

Design and implement efficient systems within the production environment, optimizing the integration of workers, machines, materials, information, and energy to maximize productivity, minimize waste, and improve overall operational efficiency. Required Candidate profile Diploma or Degree in Industrial, Mechanical or Production Engineering with proven track record in industrial engineering. The local candidates will be preferred. Perks and benefits Salary with lucrative variable performance pay.

review and execution of SOP, Master BMR and BPR, Qualification document and Validation document.Responsible for review of Executed BMR/BPR.monitoring, verification and review of IPQA activities on shop floor of Injectable Department, as applicable Required Candidate profile Deviation, Market complaint& OOS related to shop floor. QA SOPs & IPQA , Calibration& Preventive maintenance Line clearance, IPQA Activity, BMR checking, BPR Verification, Sampling activity

API Background with knowledge of Reactors, Centrifuge, Batch Charge, cGMP, BPR, Safety Guidelines, etc