91 Bpr Jobs

Job Responsibilities Manufacturing: 1. Execute and monitor routine manufacturing activities as per the batch manufacturing record (BMR). 2. Ensure production is carried out in compliance with cGMP, GDP, safety, and company procedures. 3. Operate, clean, and maintain equipment as per SOPs. 4. Maintain online documentation: BMRs, logbooks, cleaning records, and deviation reports. 5. Coordinate with QA/QC, maintenance, and stores for smooth production flow. 6. Monitor in-process parameters and escalate any deviations or abnormal observations to supervisors. 7. Ensure effective material reconciliation at the end of each batch. 8. Participate in internal audits and implement corrective and preventive actions (CAPA). 9. Train junior staff and ensure adherence to production schedules and targets.

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports. Lead handling of QMS activities. Required Candidate profile Strong knowledge of QMS, cGMP, ICH, WHO guidelines,Audit handling and documentation expertise,Leadership and team coordination,Proficiency in handling TrackWise / MasterControl or similar systems

Participate in internal and external audits (USFDA, EDQM, WHO, MHRA, etc.),Ensure compliance with GMP, ICH, and regulatory guidelines in API manufacturing.Conduct in-process checks and ensure batch release activities are done per quality procedures. Required Candidate profile Experience of QMS software Exposure to regulatory audits and good Manufacturing practices. Strong communication and documentation skills. Sound knowledge of regulatory guidelines ICH, WHO, USFDA

Role & responsibilities Responsibility of Downstream activities in bulk manufacturing facility. To ensure that Downstream batches are carried out as per manufacturing instructions following relevant Process Development description document, MFR, SOPs, BPRs, Protocols etc. and to ensure appropriate documentation in order to maintain cGMP compliance. Preferred candidate profile To understand and follow the safety practices and usage of PPEs in Bulk manufacturing facility and during process. Execution of Scale up of Development batches in Bulk manufacturing facility. Tracking of inventory of consumables used in manufacturing. Ensure Facility monitoring, readiness & maintenance of BM facility. Coordination with Engineering department on tracking and completion of preventive maintenance of Downstream Equipments and instruments. Following good documentation practices such as online documentation like BPR, equipment log, record sheets, etc. in Downstream process. Preparation of Batch production records, SOPs, record sheets and related documents for Downstream related activities in Bulk Manufacturing Facility. Review of Batch production records and related documents in Downstream process. Responsible for timely closure of Batch production records (BPRs), Protocols and reports related to the Downstream process. Coordination with Vendors on equipment and instruments qualification related to the Downstream process. Initiation and closure of change controls, deviations related to Bulk Manufacturing area. Ensure the timely revision of BPR, SOP and study protocols related to downstream process. Responsible for LMS activities as a department training coordinator. Involving in internal audits, local DCGI audits and any other regulatory agencies. Involving in training on safety related activities and imparted training to pooled staff.

Hi, Greetings from Avani Consulting!! We have job opportunities with API Manufacturing Plant for the Production Associate/Sr Associate position, Mysore Location. Job Description: Production Department Position- Associate/Executive Work Experience - +4 in API Manufacturing Location - Mysore 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 interested, kindly send your updated resume on whatsapp @ 7327039030 with the below details 1. Current CTC: 2. Expected CTC: 3. Notice Period: 4. Current Location: 5. Preferred Location: 6. Total Experience: 8. Relevant Experience in Production Process: 9. Experience in API Manufacturing: 10. Current company: 11. Qualification: 12. Experience in Documentation: 13. Reason for change: Thanks & Regards Monalisa Barik

Opening for an Pharma Compay. Location : Bhiwadi. Job Description: Hands-on experience in QA documentation Qualification and validation activities QMS (Quality Management System) activities Interested candidates shared resume on snehal@topgear@gmail.com

Hi, Greetings from Avani Consulting!! We have job opportunities with API Manufacturing Plant for the Production Associate/Sr Associate position, Mysore Location. Job Description: Production Department Position- Associate/Executive Work Experience +7 in API Manufacturing Location Mysore Qualification: B.tech in Chemical// M.Sc Chemistry with 3 years in API 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 interested, kindly send your updated resume on whatsapp @ 7015954549 with the below details 1. Current CTC: 2. Expected CTC: 3. Notice Period: 4. Current Location: 5. Preferred Location: 6. Total Experience: 8. Relevant Experience in Production Process: 9. Experience in API Manufacturing: 10. Current company: 11. Qualification: 12. Experience in Documentation: 13. Reason for change: Thanks & Regards Shweta Gupta

RAIN is seeking an Assistant Manager - Regulatory Compliance to monitor and assess the regulations and regulatory changes in European jurisdictions in alignment with the Director of Global Regulatory Compliance and with regards to business impact for Rain Carbon. This includes regulations which govern raw materials and products. The role will be a part of RAIN's Global Regulatory Compliance team. The ideal candidate will be well-informed about translation of chemical regulations into business impact and the implementation of chemical legislations (primary focus on EU) ideally in the manufacturing industry. Required Skills: University degree in chemical/technical field with focus on chemistry or biochemistry Several years of experience in translation of chemical regulations into business impact and the implementation of chemical legislations (primary focus on EU) Focus on REACH ( Registration, Evaluation, Authorization and Restriction of Chemicals ; EG 1907/2006), BPR ( Biocidal product regulation , EU 528/2012), PIC regulation ( Prior Informed Consent , EU 649/2012) Specialist knowledge of the company products and their use Ability to quickly and efficiently become familiar with laws and their implementation (focus: chemical regulations) Business fluent in spoken and written English Standard Software (MS office, SAP), Special Software for Regulatory Affairs topics including strong hands-on experience with IUCLID (SAP EHS and CHESAR knowledge considered as advantage) Major Objectives: Raw materials and products in the regulatory context : Monitoring and assessing the regulations and regulatory changes in European jurisdictions in alignment with the Director of Global Regulatory Compliance and with regards to business impact for Rain Carbon. This includes regulations which govern raw materials and products. Ensuring regulatory compliance : Coordinating (- if applicable with external support -) specific regulatory affairs related activities in order to ensure regulatory compliance for Rain Carbon products in Europe (primary focus) and non-European jurisdictions (secondary focus). The chemical regulations include REACH (focus on registrations), BPR and PIC. Representation in Industry groups : Support for positioning Rain Carbon interests in relevant and prioritized industry consortia with a focus on regulatory compliance. Tasks and Responsibilities: Raw Materials and Products in the regulatory context : Monitoring and assessing the regulations and regulatory changes in European jurisdictions from a chemical substance and downstream user perspective in alignment with the Director of Global Regulatory Compliance with regard to the business impact for Rain Carbon. This includes regulations which govern raw materials and products, focusing on regulations in the field of chemicals, environment, occupational safety and consumer safety. Products and raw materials internal inventory : Supporting the Director of Global Regulatory Compliance in developing and maintaining the internal inventory for products and raw materials. Ensuring regulatory compliance : Coordinating (- if applicable with external support -) specific regulatory affairs related activities in order to ensure regulatory compliance for Rain Carbon products in Europe. This includes national authorizations of biocidal product as well as the current and future treatment of Rain Carbon products under REACH and other chem. regulations. A main focus in the context of the REACH regulation is the work on CAS number specific dossiers, which includes the existing dossier update on the basis of new data as well the preparation of new dossiers in the context of new product development. Support for RCI representation in industry groups: Active role and/or support for the Director of Global Regulatory Compliance in Rains representation of industry groups. Focus is on industry consortia which main purpose is to ensure regulatory compliance on industry level, e.g. in the context of the REACH or BPR regulation. The support includes the preparation of RAIN specific data which might be relevant for dossier updates, keeping existing dossiers of RAIN substances conform to the Consortia updates or joint feedback to regulators. Stakeholder dialogue: Exchanging information and negotiating with internal (e.g. sales, purchasing) and external stakeholders, (e.g. regulators), in alignment with the VP Regulatory Affairs & Sustainability and the Director of Global Regulatory Compliance About the Company Headquartered in India, RAIN Industries is a multinational, Fortune India 103 manufacturing company, and among the top 10 publicly listed companies in Hyderabad. We are a leading vertically integrated producer of carbon, cement, and advanced materials with manufacturing facilities in eight countries across three continents. RAINs subsidiary companies, Rain Carbon Inc. and Rain Cements Limited, are industry leaders in their respective sectors. We are always looking for talented people to join our global organization who bring both a deep passion for their work and a constant commitment to professional excellence. RAIN is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Role & responsibilities Responsible for ensuring that all pharmaceuticals products developed with the R&D Department meet the highest quality standards. Prepare and review regulatory dossier documents for DCGI, ROW and Export market business. Ensure all the documents meet regulatory requirements and guidelines including quality. Implement and maintain quality assurance systems and procedures for dosage preparation. Ensure compliance for Good Manufacturing Practices (GMP), Good Laboratories Practices (GLP) and other relevant regulatory standards. Collect, organize and review documents from F&D, ADL and other relevant departments. Prepare and review SOPs, BMRs, BPRs, PV Protocols/Reports, Stability Protocols etc. to ensure accuracy and compliance with manufacturing protocols. Manage quality documentation and records, including standards operating procedures (SOPs), Batch records and Test reports. Compile and review Product Development Reports (PDRs) to document the formulation and development process of products. Ensure all equipment is calibrated according to the schedule and the records are maintained. Preferred candidate profile Must have experience in OSD Perks and benefits

Please share your CV on sneha.shinde@embio.co.in or kchoudhary@embio.co.in for further process.

Role & responsibilities Oversee and manage the entire manufacturing process. Handle Granulation, Compression , Coating and all other production related activities. Active calculation, dispensing of Raw Materials and batch reconciliation at various stages. In process checking at various intermediate stages of Granulation, Compression and Coating. Prepare IQ, OQ, & PQ of the process & utility equipment. Should handle process of validation batches Ensure online documentation of production activity on timely basis. Review of batch manufacturing record and other related documents for its completion of intermediate and final stage. Maintain the SOPs, Log books and other documents. BMR / BPR preparation in ERP and review.

Opening with an leading Pharma Company. 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

To carryout filling and packing activities as per BFR, BPR & SOPs. To follow & maintain current GMP standards in production area/activities. To follow day-to-day production schedule and ensure to complete production activities (filling & packing) as per schedule. To take & follow operating instructions for the shift activities from superior/Manger If any abnormality found in production area / activities, authorized to stop activity immediately & highlight to production Manager. To maintain manufacturing records online & should comply data integrity practices. Indenting, issuance & submission of BFR/BPR. Verification of Raw material & Packing material during receipt. Sample request/submission to QC after filling activity. Transfer finished goods through Finished Goods Transfer Note. Carryout cleaning of filters & storage tanks as per schedule. Ensure & Maintain cleanliness in production area as per SOP. Ensure cleaning of AHU filters as per schedule. To Check and ensure minimum stock of consumables, Log books & status labels. Ensuring preventive maintenance of all equipment as per schedule. Maintain temperature & RH within SOP limits in production area. Co-ordinate with service departments (QA, QC, stores, E & M and SCM) for various production related activities. To follow safety instructions/procedures & ensure use of safety outfit while on works. Responsible to carry out the work of his senior in the absence of senior or authorization from senior. Responsibilities Qualifications B. Pharmacy or equivalent

Job Description Conduct all tasks/ activities as per the applicable SOPs. Report any difficulty or deviation in the procedures/instructions to immediate Supervisor/Managers. Report any quality concerns or suggestions for improvements to Supervisor/ Managers.Preparation and Review of Quality Assurance SOP’s. Review of other departments SOP’s. Review of Master Documents such as BMR/BPR, Test batch monitoring protocols / process validation protocol and reports etc. Initiation and log in of Quality System document such as Deviation, Change Control, OOS, OOT, market complaint, Annual product review and Non conformities. Work Experience 3-5 Years Education Graduation in Pharmacy Competencies

Quality Assurance Executive required for reputed organisation in Navi Mumbai location Dear Professionals,, I am Sindhura C , from the Pharma Vertical of Masadir HR Services , an International Recruitment Firm. We have been retained by professionally managed organisation to recruit Quality Assurance Executive for them. The job location is in Navi Mumbai. Qualification: Graduate or Postgraduate Degree in Biological or Life Sciences with at least 3-4 years working in QA/compliance domain Experience: Min 2yrs If you are interested in exploring the above opportunity, kindly share your updated resume with me please. In case, if you are not interested, kindly feel free to refer your friends who may be interested in this. Looking forward to hearing from you soon. Thank you! Have a great day! Warm Regards, Sindhura C Associate| Global Talent Acquisition Operations | India Mobile/ WhatsApp : +91 6282564376 Email Id: sindhura.c@masadirservices.com www.masadirservices.com

• Good knowledge about of herbal products & plant Equipment's handling i.e. Extractor, Reactor, Steam distillation & spray drier etc. • Good knowledge about herbal products process, organic solvents & green Solvent. • Good communication skill & Computer skill i.e. M.S office, M.S word & M.S excel. • Good knowledge about plant documentations i.e. BPR, SOP etc. • Good handling skill of team work. • Minimum 3 years experience/ exposure of handling herbal plant. • Minimum qualification B.Sc. with Chemistry/ Photochemistry.

• Good knowledge about of herbal products & plant Equipment's handling i.e. Extractor, Reactor, Steam distillation & spray drier etc. • Good knowledge about herbal products process, organic solvents & green Solvent. • Good communication skill & Computer skill i.e. M.S office, M.S word & M.S excel. • Good knowledge about plant documentations i.e. BPR, SOP etc. • Good handling skill of team work. • Minimum 3 years experience/ exposure of handling herbal plant. • Minimum qualification B.Sc. with Chemistry/ Photochemistry.

Review& execution of SOP, Master BMR& BPR,Qualification document& Validation Document review of Executed BMR/BPR. Change control, CAPA, Risk assessment related to shop floor QA SOPs &IPQA related Documents. Required Candidate profile 1.Officer–IPQA Injectable Manufacturing 2.Sr. Officer– IPQA Injectable Deviation, Change control,Market Complaint & CAPA of respective shop floor area prepare the QA SOPs and IPQA related Documents

*For Production (Parenteral/Injectable exposure only) : > Process Incharge/Sr. Process Incharge (Officer/Sr. Officer/Executive) : - To ensure the cleanliness, environmental norms and other process of various area like Dispensing, Mixing, Filling and Terminal Sterilizer. -To complete CIP, SIP and batch manufacturing process timely. -To ensure the batch manufacturing process is done as per Batch Manufacturing record. -To co-ordinate with other departments like QA, QC, Stores, Engineering, etc. as and when required. *For Packing (Parenteral/Injectable exposure only) : >Process Incharge/Sr. Process Incharge (Officer/Sr. Officer/Executive): - To make sure that issued material is as per requirement and the material quality is as per specification. -To check the availability of packing material with proper labels and status. -To ensure that the packing activity does not start without line clearance. -To check, verify and destroy the rejection generated during packing and ensure recording of all such material. -To update the Batch Packing Record online. -To check the packing online at frequent intervals as defined in the Standard Operating Procedure. -To train personnel for the critical operations like visual inspection and labeling. *For Stores (Pharmaceutical exposure only) : >Process Incharge (Officer/Sr. Officer): -Manage inventory levels by receiving, storing, and issuing materials according to GRN (Goods Received Note) and challans. -Ensure accurate recording of stock movements using FIFO (First-In-First-Out) method. -Maintain store cleanliness and organization to prevent damage or loss of goods. -Monitor inventory turnover ratios to optimize storage capacity utilization. -Perform regular physical counts to verify accuracy of recorded stock levels. Candidate Profile: Ready to work in rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. -The above positions are for shift (rotational) operations for the plant location (Vasana-Chacharwadi) and only for experienced candidates. -Fresher candidates can share their profile on hrm.opmf-amd@otsukapharma.in Note: Otsuka Pharmaceutical India Pvt Ltd does not hire any such consultants/agents who promise interviews/jobs for monetary consideration/registration fees. Beware of such fraudulent calls.

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

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