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3.0 - 8.0 years
4 - 7 Lacs
Nagpur
Work from Office
Qualification : B.Pharma Experience : 3 to 10 yrs. Designation : Officer Salary Range : 6 to 7 Lacs PA. Unit : Injectable Kindly Find the JD. Management of Aseptic Process Simulation (Media Fill) Program. Review of quality systems such as Change Control, Deviations, CAPA, OOS, OOT, LIR, Market Complaint, FAR, Product Recall and other QAMS documents. Preparation and Review of APQR. Nitrosamine Risk Assessment of Drug Product Preparation and review of site QA SOP and review of cross-functional department SOP. Review of Batch Manufacturing Record and Batch Packing Record. Preparation, review and execution of hold time study of drug product. Preparation and review of thermal cycling and temperature excursion study If interested mail cv at :- neetij@selectsourceintl.com
Posted 1 month ago
10.0 - 20.0 years
20 - 22 Lacs
Ahmedabad
Work from Office
Role & responsibilities To develop, execute, and monitor production planning and scheduling strategies for pharmaceutical manufacturing, ensuring smooth operations, material availability, and compliance with regulatory requirements. Reporting To Head-PPC Geographic Location Ahmedabad, Gujarat, India Education: B. Pharm / M. Pharm / B.Sc. / M.Sc. / MBA (Operations / Supply Chain) or equivalent. Experience & exposure Experience: 10-15 Years years in Production Planning & Control (PPC) in Injectable Pharmaceutical Manufacturing. Key Responsibilities 1.Production Planning & Execution Develop and oversee monthly, weekly, and daily production schedules based on Sales or Demand forecasts and inventory levels Monthly Production plan preparation based on pending export, tender orders and sales forecast. Create Plan order in SAP. Monitor Daily production plan VS Actual, incase of any deviation then discuss with production team Optimize batch planning to minimize changeovers and maximize equipment utilization. Track and monitor production performance, identifying and resolving issues. 2. Inventory & Material Management Inventory Monitoring and Product availability Ensure the availability of raw materials, excipients, and packaging materials by coordinating with procurement and warehouse teams. Maintain optimum inventory levels to avoid shortages or overstock situations. Collaborate with the procurement team to forecast material requirements based on production schedules. 3. Coordination & Cross-Functional Collaboration Coordinate with Cross Function teams like Quality Assurance (QA), Quality Control (QC), Warehouse, and Engineering teams to ensure seamless production flow. Communicate production status, changes, and challenges to stakeholders in a timely manner. Work closely with regulatory teams to ensure compliance with global standards. Coordinate with PDD team for New Product Development & review existing. 4. Compliance & Documentation Ensure adherence to GMP, WHO, and other regulatory requirements. Maintain accurate documentation for production schedules, material planning, and deviations. Assist in internal and external audits by providing necessary production planning data. Preferred candidate profile Exposure Strong background in sterile/injectable formulations is mandatory. Key Skills Required Expertise in production planning, scheduling, and capacity management. Strong knowledge of GMP, WHO and other pharmaceutical regulations. Proficiency in SAP Analytical skills for demand forecasting and production efficiency improvement. Strong leadership and team coordination skills. Ability to work under pressure and manage multiple priorities.
Posted 1 month ago
2.0 - 4.0 years
1 - 4 Lacs
Ahmedabad
Work from Office
Role & responsibilities Responsible for In-process production related activities in DP manufacturing, filling, and packing sections Preparation of batch manufacturing records, process validation protocol/report of DP area and its associated records Responsible for calibration and qualification program of equipment of DP area Execution and review of IQ, OQ, PQ of equipment. Perform the Qualification/Verification of equipment's and compilation of PV documents of the DP Area
Posted 1 month ago
3.0 - 7.0 years
2 - 5 Lacs
Pune
Work from Office
Responsibilities: Operation and maintenance of bottle pack (Blow-Fill-Seal), Cap Welding Machine and control operational rejection at filling stage. Maintain quality of product (as per IPQC standard). Perform preventive maintenance of machines as per master preventive maintenance plan and record those. Optimum granules and energy consumption. Follow clean room area discipline and maintain clean room area cleaning. Record all necessary information / readings in machine operating log books / aseptic cleaning records and BPCR. Maintain facility and equipment / machine in good condition. Follow GMP and EMS SOP's. Follow the instruction received from Shift Incharge Responsible for personnel and machine safety. To ensure segregation of generated waste material as per Waste Management OCP. Implementation & Follow of EMS, OHSMS, EnMS Systems during operation. To report and investigate Environmental, Safety, Energy loss deviations / incidents, non-conformance. To understand & follow Environmental, Occupational health and safety, Energy policy. To understand and Implement the OCP for preventing, reducing or eliminating the significant aspects, Energy loss and risks in respective area. Identifying the significant environmental aspects and significant OH&S hazards through Environment aspect impact analysis and risk assessment process for all the activities of the department and maintain the same in aspect and HIRA register. Preferred candidate profile Must have worked on BFS technology
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive for Engineering Services Department In Formulation Division @ Mekaguda Department:- Engineering Services OSD Skills- Instrumentation | Utility | Process Maintenance | HVAC | Electrical | Water System Qualification :- ITI | Diploma | B Tech Mechanical & Electrical Experience :- 2-8 Years Division :- Formulation Work location :-MSNF-IV, Mekaguda Interview Date-05-07-2025 Interview Time:- 9.00AM To 2.00PM Venue Location:- MSN Formulation Unit IV, Mekaguda 37XJ+W82, Mekaguda, Telangana 509228 Contact No:- 040-304338701 | 8787 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 1 month ago
8.0 - 12.0 years
5 - 10 Lacs
Ahmednagar
Work from Office
Role & responsibilities Collaborate on formulating and analyzing research strategies tailored to market and customer demands. Oversee commercial activities, securing approvals from manufacturers and our supply team. Assist in selecting manufacturers based on available equipment and machinery for specific products. Finalize quality and quantity formulas and product specifications, submitting them to manufacturers. Coordinate the preparation and arrangement of registration samples and artwork. Liaise with manufacturers to ensure commercial production aligns with our quality and quantity standards and product specifications. Collect and review documents from manufacturers. Coordinate with external laboratories for sample and product analysis according to our standards. Finalize active pharmaceutical ingredient (API) selection based on approved specifications submitted to relevant health authorities. Review and submit Product Information Files (PIFs) to manufacturers. Submit final quality and quantity standards and product specifications for new product launches. Coordinate with external F&D support teams. Review analytical data received and support regulatory affairs (RA) team with query responses. Arrange API and working substance samples, as well as analytical data like HPLC and certificates of analysis (COAs) for the F&D team. Review all documents from external sources and provide them to the RA team. Assist the supply team in sourcing API and primary material specifications. Review manufacturers' and Opes Healthcare's certificates of analysis for finished products. Provide troubleshooting support during new and existing product launches. Plan and execute plant visits during commercial production activities. Update management on critical changes, incidents, and market complaints. Review and approve all GMP documents including SOPs, change controls, deviations, batch manufacturing and packing records, process study protocols/reports, qualification documents, specifications, and standard testing procedures (STPs). Approve apex documents such as the Quality Manual, Validation Master Plan (VMP), and Site Master File (SMF). Design, review, and approve the Quality Management System (QMS) and associated documents. Drive initiatives for continuous improvement and operational excellence. Collaborate with other departments to ensure effective implementation of the designed quality management system. Manage activities related to registration batch manufacturing. Preferred candidate profile pharma THANKS YOU REGARDS MILAP RATHOD (7486829377) HR DEPARTMENT OPES HEALTHCARE PRIVATE LIMITED
Posted 1 month ago
20.0 - 25.0 years
45 - 55 Lacs
Halol
Work from Office
Job Role : General Manager (Engineering) Education: BE Electrical & Electronics Experience : 22 to 24 Yrs (with expereince in Regulated markets and Sterile background) Responsibilities : 1. He is authorize to sign (as a doer / reviewer / verifier) A. Engineering GMP Documents B. Break Down / Preventive Maintenance Report C. Qualification Documents. D. QMS document review and closing. E. Any other documents related to QMS. Handling of Halol-1 (NOSD) Engineering Operation, HVAC, Electrical and Facility Management related activity. Preventive Maintenance approval, Instrument / Equipment inward approval, Qualification protocol and SOP review and approval. Improvements to reduce the Break down time of Production Equipments. To ensure all critical utilities as HVAC and Water systems are available round the clock as per requirement. Conceptualize and Implement Energy Conservation measures for Energy & water. Preparation of annual Revenue budget and ensure expenses are within budget. Propose annual Capital budget for finalization & implement the sanctioned Capex. Handling of Engineering & Facility modification related activity. Rolling out the Good Engineering Practices and standards in various functions of Engineering. To ensure availability of the spares and maintain inventory of critical spares having long delivery time. Standardization and Harmonization of documentation and procedure in engineering department. Ensure continuous improvement in engineering operating system in coordination with plant maintenance leaders & production team leaders to avoid breakdowns and repeated failures. Tracking of Capex and Modification related activity. Ensuring delivery of the activity in terms of safety, quality, timelines and budget. To ensure all engineering SOP, records and schedule are updated as per QMS. Participate in Technical Investigations. Participate in monthly Quality council meetings and update status of QMS documents. Ensure that QMS documents are closed as per time line. Compliance of internal and external observation points. To ensure timely completion of training related activity. Handling the Facility Management team operations for the site. To evaluate change control related to global IT division.
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Biological E. Limited (BE) invites both experienced professionals and fresh diploma holders, as well as graduates and self-driven individuals, to join its Specialty Injectables Business located in Shamirpet, Hyderabad. The available positions are listed below: INJECTABLES QUALITY ASSURANCE : Designation : Executive & Senior Executive Qualification : B. Pharm / M. Pharm / M.Sc. Experience : 3-9 Years Role : IPQA (In process QA Injectables) PRODUCTION PHARMA: Designation : Officer & Senior Officer Qualification : Diploma / B. Sc. Experience : 2-6 Years Role : Filling/Autoclave/Compounding/Lyo PRODUCTION PHARMA: Designation : Executive & Senior Executive Qualification : M. Pharmacy / B. Pharmacy/M.Sc Experience : 2-10 Years Role : Filling/Autoclave/Compounding/Lyo Quality Control: Designation : Executive Qualification : B. Pharm / M.Sc. Experience : 3-6 Years (Injectables) Role : RM/FG/Stability Microbiology: Designation : Executive Qualification : M.Sc (Microbiology/Biotechnology) Experience : 3-6 Years Role : Testing /EM Engineering: Designation : Officer/Sr.Officer/Executive/Sr.Executive Qualification : Diploma/B. Tech. Experience : 3-8 Years Role : Process Instrumentation/Utilities/Electrical Interested Candidates may Walk-in with an updated Resume, latest increment letter and payslips for the last 3 months on Sunday, Jun 29, 2025 from 09:00 am to 02:00 pm at Hotel Tabla, 1st Floor,T.S.H.B Commercial Complex, Opp. Metro Pillar Number 730, KPHB Colony, Kukatpally, Hyderabad, Telangana 500072. Candidates with relevant pharmaceutical experience may walk-in for the interview.
Posted 1 month ago
9.0 - 12.0 years
0 Lacs
Bhiwadi
Work from Office
Manage day-to-day operations of lyophilization and aseptic production lines. Ensure compliance with cGMP , FDA , EMA , and other regulatory. Oversee equipment preparation , cleanroom operations , sterile filtration Oversee API manufacturing processes
Posted 1 month ago
2.0 - 7.0 years
3 - 8 Lacs
Ahmedabad
Work from Office
Walk-in @ GOA We are hiring multiple positions for our manufacturing facility at AHMEDABAD as mentioned below. Please find our current job requirements and venue details mentioned. If any of the requirements match your current job profile, kindly walk in with your latest resume. Engineering (Instrumentation / QMS / Process Equipment maintenance) (Senior Executive / Executive / Senior Officer) Experience - 03 to 10 Years Qualification BE / B Tech with relevant functional experience in Calibration / Instrumentation / QMS activities QUALITY ASSURANCE QMS / Documentation / Validation and Qualification / Market Compliance / IPQA - (injectables) (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. QUALITY CONTROL (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M.Sc. (Organic Chemistry / Analytical Chemistry) B. Pharmacy / M Pharmacy MICROBIOLOGY (Officer / Senior Officer/ Executive) Experience - 02 to 07 Years Education - B.sc / M. Sc (Microbiology) Injectable Manufacturing (Executive/Senior Officer / Officer / Associate) Experience - 01 to 06 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma with relevant functional experience in injectable manufacturing/ Aseptic area operations/ Visual inspection / QMS activities OSD Manufacturing (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Diploma with relevant functional experience in OSD manufacturing and Packing operations / QMS activities Time and Venue : 06th July 2025, 09:30 Hrs to 17:00 Hrs ______________________________________________________ The Fern Kesarval Hotel, Verna Plateau GOA -403710 _____________________________________________________ We would be very happy if you forward or refer any of your colleagues matching the requirement. *Having relevant qualification and experience only can attend the scheduled walk-in.
Posted 1 month ago
7.0 - 12.0 years
5 - 10 Lacs
Hyderabad/ Secunderabad
Work from Office
Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com
Posted 1 month ago
2.0 - 7.0 years
4 - 9 Lacs
Hyderabad
Work from Office
Dear Aspirant , Greetings From Eugia Pharma Specialties Limited (Aurobindo Group)!!!! We glad to inform you all that we planned Walk In Interviews for below vacancies in our Manufacturing unit. Department : Quality Assurance (IPQA) No. of Vacancies : 30 Education Qualification : B. Pharmacy / M Pharmacy Experience : 2-5 Years Designation : Executive Required Skills : Aseptic Area Monitoring / Environmental Monitoring / Aseptic behavior / Media Fill / Gowning Practices / Sterility Assurance/ In Process checks in Injectable Work Location : Eugia Unit -3, Pashamylaram Walk In Details: Date : 29.06.2025 Time : 09 AM - 02 PM Venue : Aurobindo Pharma Limited - Unit - 3 Sy. No. 313, Bachupally, Hyderabad, Telangana 500090 Google Map : https://maps.app.goo.gl/qoL8vZ6EwDm5GcWb8 Contact : Mr Prabhakar / Ms Rama
Posted 1 month ago
2.0 - 7.0 years
3 - 8 Lacs
Hyderabad
Work from Office
Dear Aspirant , Greetings From Eugia Pharma Specialties , Unit ..! We glad to inform you all that we planned Walk In Interviews for below vacancies in our Manufacturing unit. Department - Production (Injectable) Qualification - M. Pharmacy / B. Pharmacy / M. Sc /B Sc / Diploma / ITI Designation - Sr. Executive / Executive/ Operators Experience - 2Yrs to 8 yr. Skills - Vial Filling/ Sealing / Autoclave / Lyo and etc Work Location : Eugia Unit -3, Pashamylaram Walk In Details: Date : 29.06.2025 Time : 09 AM - 02 PM Venue : Aurobindo Pharma Limited - Unit - 3 Sy. No. 313, Bachupally, Hyderabad, Telangana 500090 Google Map : https://maps.app.goo.gl/qoL8vZ6EwDm5GcWb8 Contact : Mr Prabhakar / Ms Rama
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive For Production Injectables In Formulation Division @ Kothur Department:- Production Injectables Qualification :- Diploma | ITI | B Tech | B Pharmacy | BSc | MSc | M Pharmacy Experience :- 2 to 8 Years Skills :- Labelling & Filling Operator | Lyophilized | Autoclave | Vial Sealing | Filling Activities | Compounding | PFS | ALUS | Ophthalmic | Cartridge | Growing Ophthalmic Division :- Formulation Interview Date:28-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- Unit-II, Kothur | Unit-V, RK Puram Venue Location :- Survey Nos.1277 & 1319 to 1324, Nandigama (Village), Kothur (Mandal, Mahbubnagar, Telangana 509001) Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 1 month ago
2.0 - 7.0 years
2 - 7 Lacs
Hyderabad
Work from Office
Walk In Drive for Engineering Services Department In Formulation Division @ Kothur Department:- Engineering Services OSD & Sterile Skills- Sterile | Electrical | Mechanical | HVAC | OSD Process Maintenance| Sterile Maintenance| Utility | Instrumentation Qualification :- ITI | Diploma | B Tech Mechanical & Electrical Experience :- 2-8 Years Division :- Formulation Work location :-MSNF-II, Kothur , MSNF-IV, Mekaguda, MSNF-V, RK Puram Interview Date-28-06-2025 Interview Time:- 9.00AM To 2.00PM Venue Location:- MSN Laboratories Pvt Ltd , Formulation Unit -II, Survey Nos.1277 & 1319 to 1324, Nandigama (Village), Kothur (Mandal, Mahbubnagar, Telangana 509001) Contact No:- 040-304338701 | 8787 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.
Posted 1 month ago
2.0 - 7.0 years
1 - 2 Lacs
Hyderabad
Work from Office
Role & responsibilities Having Injectable Experience of Shop floor activities like vial washing, compounding, filtration, filling and Stoppering, Sealing, Autoclave, Garment Washing machine, Lyophilizes, Ophthalmic, Suspensions, Handling of Complex Products. Having Injectable Experience of Shop floor supervising activities like vial washing, compounding, filtration, filling and Stoppering, Sealing, Autoclave, Garment Washing machine, Lyophilizes, Ophthalmic, Suspensions, Handling of Complex Products, Lyophilizer Operations and Training and QMS.
Posted 1 month ago
1.0 - 3.0 years
1 - 3 Lacs
Dod Ballapur, Bengaluru
Work from Office
POSITION: FILLING OPERATOR (entry level) runs machines that fill sterile medicines Production of sterile injectable products like vials, ampoules, cartridges, and pre-filled syringes (PFS). COMPANY: OneSource CDMO Known for sterile injectables, prefilled syringes, autoinjectors, and soft gel capsules. Department: production, manufacturing, formulation Aseptic Filling Operations: Operate machines inside cleanrooms or isolators to fill sterile drug products without contamination. Machine Setup & Maintenance: Set up, calibrate, clean, and dismantle equipment like vial filling machines, lyophilizers, and sterilizers, cartridge filling/washing, Ampoule filling Visual Inspection & Leak Testing: Check for particulate matter, proper sealing, and container integrity.
Posted 1 month ago
5.0 - 8.0 years
4 - 6 Lacs
Pune
Work from Office
Role & responsibilities 1. To maintain all the documents as per SOP & cGMP. 2. Handling of QMS activities like change control, deviation, CAPA and QRM of production department. 3. Planning and execution of department trainings as and when required / Training of personnel on department SOP. 4. Market complaints investigation of products manufactured at Agio Pharmaceutical Limited and ensuring completeness of CAPA. 5. To ensure the completeness of investigation & compliance of market complaints for injection department. 6. Ensure the implementation of current regulatory requirements at injection department as applicable. 7. Preparation of Standard Operating Procedures at injection department. 8. To perform job assigned by Department Head as and when required. 9. Online in-process entry & create batch order in ERP system. 10. Generate purchase request in ERP system. Preferred candidate profile Reputed Pharma Background
Posted 1 month ago
12.0 - 20.0 years
9 - 15 Lacs
Hosur
Work from Office
Greetings! We are looking for Formulation Research & Development Scientist - Injectables for a leading Pharmaceutical company based at Hosur location. Responsibility: 1. Develop robust formulations and processes for general products to various markets such as Regulatory, Semi-regulatory, ROW, and Domestic with application on QbD as needed. 2. Monitoring and supporting the formulation team for the completion of allocated projects within the timelines by trouble shooting the concerns involved. 3. Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timeIines. 4. Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports). 5. Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for filing purpose. 6 Interaction with API/Excipient manufacturers, CROs and CMOs as needed. 7. Interaction with external testing laboratories as needed. 8. Work proactively with other cross-functional groups to execute all product related activities such as Manuticturing and Packaging master records, SOPs and protocols etc. 9. Co-ordination with other Dept. like Purchase. QC/QA, RA, ADD, Production Eng. etc. related to product development activity. 10. Review SOPs, as well as appropriate documentation and test results for accuracy and coin pleteness and coinpl iance with SOPs/GM P requirement. 11 . Coordinate with RA for fiI ing AN DAs and addressing deficiencies; provide relevant documents to Regulatory Affairs in a timely man ner for ANDA fil ings and Supplements filing. 1 2. Review of batch records, process characteri xation reports, validation reports and investigation reports. Interested Candidates Kindly share your updated cv to uma@bvrpc.com
Posted 1 month ago
2.0 - 6.0 years
2 - 6 Lacs
Visakhapatnam, Srikakulam, Vizianagaram
Work from Office
Role & responsibilities Job summary We are looking for an individual to perform filling/washing and sterilization operations within GMP (Good Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines, ensuring compliance with quality standards, GMP, and regulatory requirements as per schedule. " Roles & Responsibilities Perform filling, washing, sterilization operations as per the day plan, executing batch production records. Participate in filling area line clearance activities and perform machine cleaning operations. Handle material dispensing and issuance from the warehouse. Issue discrepancies, work with cross-functional departments to close discrepancies, and implement appropriate corrective actions. Compliance with GMP, safety standards, and SOPs (Standard Operating Procedure) for designated manufacturing equipment. Maintain records in machine operation log books. Maintain manufacturing equipment to ensure correct functionality and calibration compliance. Actively engage in validation and qualification activities for all manufacturing area machines. Promote safety awareness and improvements, engage in continuous improvement activities, and adhere to the company's safety rules. Report all unsafe matters, near misses, and accidents. Preferred candidate profile Educational qualification and work experience Educational qualification: A Diploma or B.Pharm. Minimum work experience: 4 to 6 years of experience in batch formulation operations Skills & attributes Technical Skills Proficiency in comprehending and overseeing sterile and fill finish operations in pharmaceutical manufacturing, demonstrating familiarity with the processes involved. Practical experience and hands-on knowledge in executing sterile and fill finish operations, showcasing the ability to actively participate in and manage these critical manufacturing processes. Practical expertise in equipment validation, process validation, and cleaning validation, demonstrating the ability to validate and ensure the reliability of manufacturing equipment and processes. Behavioral skills Effective listening skills, ensuring a comprehensive understanding of information. A keen eye for detail, ensuring accuracy and precision in tasks. Awareness and sensitivity to deadlines, ensuring timely completion of tasks. Analytical skills and the ability to troubleshoot, enabling effective problem-solving. Strong interpersonal skills and the ability to work well in a team, fostering collaboration and positive team dynamics. Location: Pydibhimavaram Dr Reddy's Formulations Limited(DFL-02) Injectable Facility, Aseptic Manufacturing Hiring For : Filling,Compounding,Autoclave,Lyo Operators, PM(Preventive Maintenance),Documentation, MS Office
Posted 1 month ago
0.0 - 5.0 years
0 - 1 Lacs
Ankleshwar
Work from Office
BUILD CAREER WITH CHIRON ! WALK IN INTERVIEW On 29 June 2025, Sunday TIME: 10:00 AM to 2:00 PM MANUFACTURING Qualification: M.Sc / B.Sc (Micro, Biotech, Virology, Biochemical) / B.Tech / Diploma/ BE Experience 0 5 Years Production: Drug substance Qualification: M.Sc / B.Sc (Micro, Virology, Biochemical) / B.Tech / Diploma Sterile aseptic operation Autoclave /DHS operation Automated CIP/SIP operation Cell culture Aseptic operation Zonal Centrifuge operation Facility commissioning QMS/ Deviation/ Change control/ CAPA/ Investigation of deviation
Posted 1 month ago
0.0 - 5.0 years
0 - 1 Lacs
Ankleshwar
Work from Office
Formulation/ Vaccine Drug Product Qualification: M.Sc / B.Sc (Micro, Virology, Biochemical) / B.Tech / Diploma Autoclave operation Formulation Filling (Vials , BFS, PFS) Vial Washing, Depyrogenation C- Rabs, O-Rabs, Isolator Sterile aseptic operation Sealing & Capping BMR/ QMS
Posted 1 month ago
18.0 - 22.0 years
20 - 35 Lacs
Visakhapatnam, Vizianagaram
Work from Office
Role & responsibilities Lead and manage the Engineering department with a focus on Process Engineering and Utilities. Plan, design, and implement engineering systems to support sterile and non-sterile pharmaceutical manufacturing. Ensure uninterrupted operation and compliance of all utility systems including HVAC, WFI, clean steam, compressed air, chilled water, and effluent treatment. Develop and implement SOPs for engineering operations, preventive maintenance, and calibration. Ensure compliance with cGMP, GEP, and regulatory requirements for all engineering activities. Lead capital projects including facility upgrades, equipment installation, and utility expansions. Coordinate with QA, Production, and Validation teams for timely execution of qualification and validation activities. Monitor and control energy consumption and implement energy-saving initiatives. Ensure timely execution of preventive and breakdown maintenance for all equipment and utilities. Lead root cause analysis and implement CAPA for engineering-related deviations and failures. Ensure readiness for regulatory inspections and audits by maintaining documentation and compliance. Develop and manage engineering budgets, procurement plans, and vendor management. Lead the recruitment, training, and development of engineering personnel. Ensure safety practices are followed across all engineering operations. Drive continuous improvement initiatives in process efficiency, equipment reliability, and utility performance. Ensure timely review and approval of engineering documents including URS, DQ, IQ, OQ, PQ, and validation protocols. Should have Knowledge on TPM Principless Drive Asset Robustness Program with Energy Efficiency. Coordinate with external agencies for statutory compliance related to utilities and infrastructure. Ensure proper documentation and control of engineering records and drawings. Support technology transfer and scale-up activities from R&D to commercial production. Any other assignment given by higher management. Preferred candidate profile Educational qualification : B.E./Btech or M.E./M.Tech in Mechanical, Electrical, Chemical, or related engineering discipline. Minimum work experience: 15 to 20 years in pharmaceutical manufacturing with strong exposure to sterile operations and utility systems. Skills & attributes: Technical Skills Expertise in utility systems (HVAC, WFI, clean steam, etc.) and process equipment. Experience in project management, equipment qualification, and validation. Knowledge of regulatory requirements (USFDA, EU GMP, WHO, etc.). Familiarity with engineering documentation and QMS systems. Hands-on experience in energy management and automation systems. Behavioural skills Strong leadership and team management capabilities. Excellent problem-solving and decision-making skills. Effective communication and cross-functional collaboration. High attention to detail and commitment to compliance and safety.
Posted 1 month ago
5.0 - 10.0 years
3 - 7 Lacs
Dahej
Work from Office
Require engineering experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's. Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Autoclave & Packing machines. Perform breakdown maintenance, corrective maintenance, electrical maintenance, mechanical maintenance, and preventive maintenance on equipment such as injectables, sterile machines, compression, shifter, rotator, etc. Conduct routine checks to identify potential issues before they become major problems. Troubleshoot and resolve technical issues related to plant operations. Collaborate with other teams to optimize production processes and improve overall efficiency. Ensure compliance with safety protocols and quality standards. Documentation knowledge like DQ, IQ, OQ. Note: Immediate joiners will be preferred. Share resume on dipika.parmar@milanlabs.com
Posted 1 month ago
1.0 - 6.0 years
2 - 6 Lacs
Visakhapatnam
Work from Office
Job Role: Junior/ Assistant Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/ BSc (Full time) Years of Experience: 1 to 6 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.
Posted 1 month ago
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