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7.0 - 12.0 years
3 - 7 Lacs
sanand, ahmedabad
Work from Office
Roles and Responsibilities Ensure compliance with regulatory requirements for equipment qualification, utility qualification, area qualification, transport validation, smoke testing, injectables, sterile, injection, vial washing, isolators, insulators, terminal sterilizer, RABS, Automatic leak testing machine chambers. Utility qualification (HVAC, WFI, PW etc), Facility and Area Qualification. Air flow visualization study (Smoke study) Develop and implement effective QA procedures to maintain high standards of production. Collaborate with cross-functional teams to resolve quality issues and improve processes. Maintain accurate records of all QA activities, Prepare and develop IQ,OQ,PQ & RQ p...
Posted 2 months ago
5.0 - 8.0 years
4 - 8 Lacs
vadodara
Work from Office
Role & responsibilities APQR Preparation & Management: Collect, compile, and analyze data from various departments (Production, QC, QA, Warehouse, etc.) for APQR. Ensure timely preparation and completion of APQRs for all marketed products. Review trends in product quality, deviations, complaints, OOS/OOT results, and change controls. Compliance & Documentation: Ensure APQRs are prepared in accordance with GMP guidelines (e.g., USFDA, & EU). Maintain accurate and complete documentation of APQRs and related records. Coordinate with regulatory affairs for submission of annual reports when required. Cross-Functional Coordination: Liaise with Production, QC, QA, and other departments to gather ne...
Posted 2 months ago
2.0 - 7.0 years
2 - 7 Lacs
hyderabad
Work from Office
Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 8 years of experience for the below positions at its Vaccine Business, Shamirpet, Hyderabad: Designation: Sr. Executive/Executive/Sr. Officer/Officer Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI PRODUCTION BULK MANUFACTURING (DRUG SUBSTANCE / ANTIGENS) Desired Experience: Applicants with relevant experience in vaccine, biosimilars, or injectable manufacturing will be considered. Perform upstream and downstream activities for bacterial or viral antigens. Execution of production batches in both upstream and downstream areas. Focus on timely execution to ensure that the proces...
Posted 2 months ago
0.0 - 3.0 years
2 - 5 Lacs
kannur
Work from Office
Medcare Hospitals Medical Centres is looking for Technician - CSSD to join our dynamic team and embark on a rewarding career journey. Sterilize and maintain medical instruments and equipment. Ensure proper inventory of sterile supplies and their distribution. Monitor adherence to infection control protocols. Maintain detailed records of sterilization activities. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.
Posted 2 months ago
0.0 - 2.0 years
2 - 4 Lacs
kannur
Work from Office
Medcare Hospitals Medical Centres is looking for Junior Technician - CSSD to join our dynamic team and embark on a rewarding career journey. A Junior Technician - CSSD (Central Sterile Supply Department) is responsible for assisting with the cleaning, sterilization, and distribution of medical equipment and supplies used in healthcare facilities. Their tasks may include inspecting and assembling surgical instrument sets, operating sterilization equipment, maintaining accurate records of inventory and usage, and ensuring compliance with infection control protocols. They should have knowledge of sterilization techniques and equipment. Loading the materials for sterilizationReceiving, checking ...
Posted 2 months ago
3.0 - 8.0 years
1 - 4 Lacs
chennai
Work from Office
Roles and Responsibilities Operate autoclave equipment to sterilize medical instruments and equipment according to established protocols. Perform cleaning, washing, and drying procedures on surfaces and objects using various cleaning solutions. Ensure proper functioning of all CSSD (Central Sterile Supply Department) equipment by performing routine maintenance tasks. Maintain accurate records of inventory management, including tracking stock levels, ordering supplies, and receiving deliveries. Collaborate with other team members to ensure efficient workflow and maintain high-quality standards. Desired Candidate Profile 3-8 years of experience in a hospital setting with exposure to CSSD opera...
Posted 2 months ago
2.0 - 7.0 years
0 - 2 Lacs
aurangabad
Work from Office
Roles and Responsibilities Conduct quality control analysis using HPLC, GC, UV, spectrophotometer, sterile techniques, and other relevant methods. Ensure compliance with USFDA, GMP, GLP regulations during regulatory audits. Develop and maintain SOPs for laboratory operations and testing procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Perform stability studies on APIs and finished products as required. Desired Candidate Profile 2-7 years of experience in a pharmaceutical industry setting with expertise in QC analysis. MS/M.Sc(Science) degree in Chemistry or related field; Strong understanding of analytical instruments such as HPLC, GC, UV s...
Posted 2 months ago
3.0 - 8.0 years
3 - 6 Lacs
bengaluru
Work from Office
Quality assurance, Change management, Change control, APQR's, Media fill, Microbiology Compliance and Documents handling in software
Posted 2 months ago
12.0 - 15.0 years
10 - 18 Lacs
navi mumbai
Work from Office
Role & responsibilities Regulatory Submissions: Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports) Ensure compliance with current USFDA regulations and guidance documents FDA Interactions: Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings) Participate in and support FDA meetings as the regulatory lead Handle Controlled Correspondence with the FDA for product development and regulatory strategy Product Expertise: Provide regulatory support for complex formulations , including injectables and liquid dosage forms Collaborate with R&D, QA, QC, ...
Posted 2 months ago
15.0 - 24.0 years
20 - 30 Lacs
halol
Work from Office
Title: Parenteral Line Manager Job Grade: G9 Senior Manager Educational Qualification: B.Pharm / M.Pharm Location: Baska, Gujarat Experience: Knowledge of parenteral manufacturing operations Understanding regulatory guidelines Leadership & Team Management Skills Problem Solving & Decision-Making Proficiency in handling production documentation & compliance Min. 15 years of experience working in sterile manufacturing plant or Block In-charge experience Position Summary Responsible for plant operations from material procurement to product dispatch along with operational activities, manufacturing actions, lean management, training, regulatory compliance, cross functional coordination, new produ...
Posted 2 months ago
2.0 - 5.0 years
6 - 6 Lacs
mumbai, thane
Work from Office
Job Role: Designing of HVAC Systems & Clean Room for Pharmaceutical (Sterile/non sterile, inject able, tablet, capsule, Betalactum, liquid mfg. plants), Biotech Projects, (as per the GMP, WHO, US-FDA, ASHRAE, SMACANA, etc guidelines. Heat load Calculations and HVAC Equipments selections like chillers, cooling towers, AHU, chilled water control accessories Etc. Detailing and review of various HVAC drawing like Air flow diagram, Pr. Zoning, system zoning, equipment zoning layouts, Ducting layouts, RCP layouts, CHW & HW P&ID, HVAC Piping layouts etc. Designing of clean rooms as per class 1,00,000 class 10,000, class 1000. Etc. knowledge of Modular partitions & False ceiling etc. Preparation of ...
Posted 2 months ago
2.0 - 7.0 years
3 - 4 Lacs
navi mumbai
Work from Office
Role & responsibilities To Assist Technician effectively and efficiently perform decontamination procedures for Theatre and other Hospital departments, according to hospital policy Receiving, decontamination and packing Packing of syringes, instruments and special trays. Maintaining the cleanliness of the deptt. And dusting of issuing area, sterilization area. Sterilizing and validation. Storing and distribution of sterile items to user areas. Batch monitoring Preparation of various dressing materials Cleaning the Department according to the protocol. Maintenance of the equipment. Record maintenance To provide sterile instruments and other sterile items used in patient care. To maintain reco...
Posted 2 months ago
5.0 - 10.0 years
5 - 9 Lacs
amritsar
Work from Office
Role & responsibilities : Equipment Qualification DPI liquid Injection Cleaning Validation Ampoule ,Vial Washing Media Fill Leak Test Line Clearance In Process Validation( Related to sampling ) Dental cartridge BMR/BPR
Posted 2 months ago
5.0 - 8.0 years
5 - 8 Lacs
bengaluru
Work from Office
Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team i...
Posted 2 months ago
3.0 - 7.0 years
3 - 7 Lacs
visakhapatnam
Work from Office
Investigate quality issues within manufacturing and quality laboratories Examine deviations, out-of-specification results, and atypical investigations Identify root causes and suggest effective corrective action plans Ensure all reports comply with regulatory requirements and company policies Contribute to moderately complex projects, managing your own time to meet targets Develop plans for short-term work activities within a collaborative team environment Apply skills and discipline knowledge to contribute to work within the Work Team Make decisions to resolve moderately complex problems in standard situations Work under general supervision, following established procedures and general inst...
Posted 2 months ago
3.0 - 7.0 years
2 - 7 Lacs
pithampur, madhya pradesh, india
On-site
Job Profile: Responsible for technology transfer in sterile product. Responsible for technology transfer from R&D to plant, plant to plant and third party to plant. Responsible to perform initial risk assessment of transferred project. Responsible to review analytical method documents. Desired Candidate Profile Candidate Should be from Pharma - injectable formulation background Should have knowledge of regulatory market
Posted 2 months ago
3.0 - 8.0 years
3 - 8 Lacs
pithampur, madhya pradesh, india
On-site
Role & responsibilities To follow safety rules in the premises according to the company norms. Responsible for operation and maintenance of Ampoule Filling machine & other equipment's of filling area of Pharma Sterile Injectable Plant. Monitoring of DP, RH and temperature in aseptic processing area. To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP. Responsible for operation and cleaning of area equipment present in the filling area Responsible to perform the in process checks during filling. To perform aseptic area cleaning and coordinating with engineering department as per the schedule. Operation and cleaning of all Aseptic area equipment, change ...
Posted 2 months ago
2.0 - 7.0 years
0 Lacs
manesar
Work from Office
Reviewing submission related documents including Inactive Ingredient Evaluation, Q1/Q2, Product Development Report, Quality Plan, Product Manual, Trade dress, Specifications, Master Packaging Card and Validation Protocols/Reports etc. DMF Review for ANDA submissions. Outlining requirements for labelling, storage and packaging for FDA submission. Compilation of ANDA sections of US market for sterile dosage form. Review of manufacturing related documents such as BMR, BPR and Stability study Protocols /Reports etc. To draft response and timely submission for regulatory deficiencies. To coordinate with cross-functional teams for regulatory requirements. Keeping up to date with regulatory guideli...
Posted 2 months ago
15.0 - 18.0 years
25 - 30 Lacs
guwahati
Work from Office
Job Role : Block Head (Engineering) Grade : Senior Manager Location : Guwahati Experience : 15+ Years (experience in lyophilizer ) Qualification : BE. Instrumentation Overseeing the engineering functions of parenteral block. Coordination with production personnel, contractors & machine manufactures to sort out machine related problems, major and minor modifications for smooth running in process. Tracking and maintaining the critical spares required for preventive and routine maintenance Planning various maintenance schedules and lead the team of engineering to ensure implementation of the schedules with the help of junior sub-ordinates for improving the overall reliability of the equipments....
Posted 2 months ago
1.0 - 5.0 years
1 - 4 Lacs
bengaluru
Work from Office
Job Title: CSSD Technician Company Name: Manipal Hospitals Job Description: The CSSD Technician will be responsible for the effective cleaning, sterilization, and management of surgical instruments and medical equipment in the Central Sterile Services Department (CSSD). This position requires adherence to strict sterilization protocols, ensuring all equipment is ready for surgical procedures, and maintaining compliance with health and safety standards. The technician will also assist in the organization and inventory of surgical instruments, while maintaining accurate records of sterilization processes. Key Responsibilities: - Perform cleaning, decontamination, and sterilization of surgical ...
Posted 2 months ago
2.0 - 7.0 years
4 - 9 Lacs
ahmedabad
Work from Office
Role & responsibilities #opportunities with Intas Pharmaceuticals Link to Apply: https://lnkd.in/dqFpYSSY Virtual Walk In Drive for PFU Job Location: Plasma Fractionation Centre, Ahmedabad Date: Monday, 22nd September 2025 Time: 10:00 AM to 01:30 PM Mode: Virtual MS Teams Positions: Executive / Sr. Executive / Technician Department: Manufacturing Filling (Injectables) Qualification: B.Pharm / M.Pharm / ITI Experience: 2- 15 years (Filling Lyophilization) • 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. • Executio...
Posted 2 months ago
3.0 - 8.0 years
5 - 9 Lacs
visakhapatnam, srikakulam, vizianagaram
Work from Office
Qualification: Diploma / B.Tech / B.Pharma Experience: 38 years in Cartridge/PFS Line filling. Must have hands-on experience with Bausch Strobel or Syntegon filling machines (should be clearly mentioned in the resume)
Posted 2 months ago
4.0 - 9.0 years
2 - 7 Lacs
hyderabad
Work from Office
PRODUCTION INJECTABLES: Designation : Officer & Senior Officer Qualification : Diploma / B. Sc. Experience : 3-7 Years The candidate should possess the following skills: Hands on experience in Operation & Cleaning of Vial Washing machine, Depyrogenation Tunnel, Automatic Vial Filling and Vial Sealing machine & Automatic PFS filling machine. Hands on experience in Operation & Cleaning Lyophilizers with Auto Loading & Unloading Systems (ALUS). Exposure in Aseptic process activities, Aseptic Techniques, Aseptic filling & sealing activities and Media fill activities. Hands on Experience in Operation of Autoclaves & Terminal Sterilizers; Preparation of Autoclave loads, Loading & Unloading of Auto...
Posted 2 months ago
2.0 - 5.0 years
5 - 9 Lacs
thane
Work from Office
Patient Care: Assist in the pre- and post-treatment care of IVF patients. Monitor patients during procedures, such as egg retrievals, embryo transfers, and other fertility treatments. Provide emotional support and counseling to patients during their fertility journey. Medication Management: Administer medications as per the IVF protocols, including hormone injections. Educate patients on the correct administration of medications at home. Ensure accurate documentation of administered medications in patient records. Assisting with Procedures: Assist doctors during ultrasound scans, egg retrieval, embryo transfer, and other fertility-related procedures. Prepare the procedure room with sterile i...
Posted 2 months 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 Skills- OSD ( Electrical | Mechanical) | Sterile Mechanical | HVAC | Water System Qualification :- ITI | Diploma | B Tech Mechanical & Electrical Experience :- 2-8 Years Division :- Formulations Work location :-MSNF-II, Kothur Interview Date- 20-09-2025 Interview Time:- 9.00AM To 2.00PM Venue Location:- Unit-II Kothur, 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 C...
Posted 2 months ago
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