73 Bpr Jobs

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

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

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.