109 Autoclave Jobs - Page 2

Preparation of microbiology media Maintenance and calibration of Balance, Autoclave, water bath, LAF, BSC, Microscope etc. Performs microbiological testing in accordance with standard procedures Collect and analyse data to draw conclusions and recommend actions Apply appropriate methodologies and data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement. Maintenance of standard Reference Materials, Chemicals, Reagents and Glassware used in the laboratory. Maintains the laboratory quality assurance systems to assure validity of data Perform or assist vendor in the installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) of laboratory instruments and equipment. Maintain accurate, up to date and concise laboratory records Supports a microbiological sampling and testing program. Understand and use basic laboratory safety equipment and instructions, precautions in handling and disposing of biological materials, in accordance with local environmental regulations. Troubleshoot basic instrument or methodology problems. Qualifications 4-6 years experience of working in food testing laboratory. Strong knowledge of Food microbiology analysis. Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Preparation of microbiology media Maintenance and calibration of Balance, Autoclave, water bath, LAF, BSC, Microscope etc. Performs microbiological testing in accordance with standard procedures Collect and analyse data to draw conclusions and recommend actions. Apply appropriate methodologies and data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement. Maintains the laboratory quality assurance systems to assure validity of data Maintain accurate, up to date and concise laboratory records Supports a microbiological sampling and testing program. Understand and use basic laboratory safety equipment and instructions, precautions in handling and disposing of biological materials, in accordance with local environmental regulations. Qualifications 2-3 years experience of working in food testing laboratory. Strong knowledge of Food microbiology analysis. Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Preparation of microbiology media Maintenance and calibration of Balance, Autoclave, water bath, LAF, BSC, Microscope etc. Performs microbiological testing in accordance with standard procedures Collect and analyze data to draw conclusions and recommend actions Apply appropriate methodologies and data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement. Maintains the laboratory quality assurance systems to assure validity of data Maintain accurate, up to date and concise laboratory records Supports a microbiological sampling and testing program. Understand and use basic laboratory safety equipment and instructions, precautions in handling and disposing of biological materials, in accordance with local environmental regulations. Additional Information Good interpersonal and communication skills. Energetic, flexible and innovative. Able to work independently and to coordinate several activities simultaneously. Good in communication, read and write in English and local language. Acts quickly and decisively. Knowledge in Microsoft Office (such asMicrosoft Word, Excel, Power Point, & etc.),

Role & responsibilities To maintain a clean and sterile OT. To clean and pack the instruments and autoclave and provide enough sets and linen. To maintain the autoclave-machine and eto machine. To pack and autoclave sufficient dressing sets, other set’s like bone-marrow, ICD etc. For use in the floors. To help in cleaning and fumigation of the OT. To dispatch the specimen as and when required. To see that all hospital policies are followed. Preferred candidate profile Immediate Joiners will be preferred.

Qualification : Bsc in OT Tech. / Diploma in OT Tech. Must have exposure as Operation Theatre Technician with comprehensive exposure to various surgical specialties including Urology, Neurosurgery, Orthopedics, Gynecology, General Surgery, and Laparoscopy etc. Maintains and keeps the operating room and ensures everything is running smoothly before the conduct of surgery. Cleanse and disinfect surgical instruments and or equipment after surgeries. Prepare surgical instrument and equipment for autoclaving/sterilization per protocol Maintains and keeps all surgical tools sterile and orderly. Maintains and keeps all equipment clean and functional. Order and maintain adequate necessary supplies in the operating room. Prepares the patient before and after surgery by washing and disinfecting the area for surgery. Prepare necessary equipment and instrument prior to procedure/surgery. Assists in bringing the patient to the operating room. Attends to the needs of the patient while inside the operating room. Assist surgeon during the procedure. Assist nursing staff in keeping patient safe during the procedure by assisting RN with the application of restraints and following the recommended protocol. Provides assistance to the surgical team and coordinates very closely with the doctors, nurses and laboratory staff. Clean and disinfect operating room area after each procedure/surgery. Reports any defective equipment and instrument for repair or replacement. Assist other staff in discharging patient as needed.

Responsible for cleaning, sterilizing, inspecting, & packing surgical instruments; maintaining records; ensuring infection control; coordinating with OT/ICU. Requires knowledge of sterilization,attention to detail, & physical stamina.NABH guildeline.

JOB RESPONSIBILITIES QC Executive ( Microbiology )Quality Control Head Quarter : Faridabad Purpose of the position : - To ensure that water sampling, media preparation and used media destruction is done as per approved procedure. Job Responsibilities :- 1. Responsible for all type of water sampling & analysis. 2. Responsible for operation and calibration of pH meter and weighing balance. 3. Responsible for destruction of used media/used plates and used cultures. 4. Responsible to verify logbook of autoclave, water sample inward, media management, pH meter, Laminar Air Flow and weighing balance etc. 5. Responsible for media preparation in absence of other team member. 6. Responsible for Analysis of Bioburden Sample testing of in-process, finished product & raw materials samples as per approved standard operating procedure. 7. Responsible for timely submission, review, approved and release of reports related to microbiology section. 8. Responsible for culture management as per approved protocol. 9. Responsible for Preparation of culture Suspension. 10. Responsible for Growth Promotion Test for all the dehydrated media as per standard operating procedure. 11. Responsible for Revival and Sub culturing of Microorganisms. 12. Responsible for Environmental Monitoring by Settle Plate Method & Surface swab method. 13. Responsible for performing Preservative Efficacy Test. 14. Responsible for all admin related work. 15. Responsible for reporting any Non conformity/OOS/Deviation related to water and bio burden samples. 16. Responsible for reporting of DCR for any changes related to microbiology section. . 17. To provide practical training to newcomer of QC-Microbiology Section. 18. Responsible for maintaining stock of media & materials needed for analysis. 19. Functional reporting shall be as per departmental organogram. 20. Responsible to ensure the compliance of the SOP’s applicable to QC-Microbiology. 21. Any other task assigned by your Reporting Manager. The Job Responsibilities may be reviewed / added as per company requirements from time to time.

Walk In Drive For Production Injectables In Formulation Division @ Jadcherla Department:- Production Injectables Qualification :-ITI| BA | Diploma |B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, 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.

WALK-IN INTERVIEW FOR EXPERIENCED PROFESSIONALS Job Location: Hyderabad Experience: 2 to 10 Years Qualification: ITI / Diploma / B.Sc / B.Pharmacy / M.Sc Designations: Operator Sr. Operator Jr. Executive Executive Sr. Executive Openings in the Following Areas: 1. Drug Substance (Bioprocess) Roles & Responsibilities: Upstream Process: Cell Culture Fermentation Autoclave Operation Downstream Process: Virus Culture Centrifugation Tangential Flow Filtration (TFF) Purification Chromatography 2. Drug Product (Formulation & Filling) Roles & Responsibilities: Formulation Activities Filling (Vials, BFS, PFS) Operating Equipment in: Closed RABS (C-RABS) Open RABS (O-RABS) Isolators Sealing and Capping Vial Washing & Autoclaving 3. Packing & Visual Inspection Roles & Responsibilities: Primary and Secondary Packing Operations Handling Track and Trace Systems Operating Labeling and Cartonator machine Documentation & SAP Entries Visual Inspection of Vials & Pre-Filled Syringes (PFS) Note: Candidates with relevant experience in regulatory and compliance environments (USFDA, EU GMP, etc.) will be preferred. Please bring: Updated resume, latest salary slips, passport-size photo, and original certificates.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: WFA - HCM. Experience1-3 Years.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: Payroll(HCM). Experience3-5 Years.

Role Purpose The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs. Do Support process by managing transactions as per required quality standards Fielding all incoming help requests from clients via telephone and/or emails in a courteous manner Document all pertinent end user identification information, including name, department, contact information and nature of problem or issue Update own availability in the RAVE system to ensure productivity of the process Record, track, and document all queries received, problem-solving steps taken and total successful and unsuccessful resolutions Follow standard processes and procedures to resolve all client queries Resolve client queries as per the SLA’s defined in the contract Access and maintain internal knowledge bases, resources and frequently asked questions to aid in and provide effective problem resolution to clients Identify and learn appropriate product details to facilitate better client interaction and troubleshooting Document and analyze call logs to spot most occurring trends to prevent future problems Maintain and update self-help documents for customers to speed up resolution time Identify red flags and escalate serious client issues to Team leader in cases of untimely resolution Ensure all product information and disclosures are given to clients before and after the call/email requests Avoids legal challenges by complying with service agreements Deliver excellent customer service through effective diagnosis and troubleshooting of client queries Provide product support and resolution to clients by performing a question diagnosis while guiding users through step-by-step solutions Assist clients with navigating around product menus and facilitate better understanding of product features Troubleshoot all client queries in a user-friendly, courteous and professional manner Maintain logs and records of all customer queries as per the standard procedures and guidelines Accurately process and record all incoming call and email using the designated tracking software Offer alternative solutions to clients (where appropriate) with the objective of retaining customers’ and clients’ business Organize ideas and effectively communicate oral messages appropriate to listeners and situations Follow up and make scheduled call backs to customers to record feedback and ensure compliance to contract /SLAs Build capability to ensure operational excellence and maintain superior customer service levels of the existing account/client Undertake product trainings to stay current with product features, changes and updates Enroll in product specific and any other trainings per client requirements/recommendations Partner with team leaders to brainstorm and identify training themes and learning issues to better serve the client Update job knowledge by participating in self learning opportunities and maintaining personal networks Deliver NoPerformance ParameterMeasure1ProcessNo. of cases resolved per day, compliance to process and quality standards, meeting process level SLAs, Pulse score, Customer feedback2Self- ManagementProductivity, efficiency, absenteeism, Training Hours, No of technical training completedMandatory Skills: Legal Services. Experience1-3 Years.

Decontamination, sterilization, and preparation of surgical instruments, equipment, and supplies in accordance with established protocols and standards. Ensure all sterile processing activities in a safe & efficient manner.

"Hiring Event Announcement" MFG Production Operators (ITI): 3 to 8 Experience in Injectable production, filling, dispensing, sterilization, autoclave, batch record review etc., activity MFG Packing Operators ( ITI): 3 to 8 Experience in Injectable packing activity. Date & Time : 31st May 2025 || 09 AM to 3 PM IST Venue : Ahmedabad (Invites will be shared based on your shortlisting) Registration Link copy : https://talentcommunity.baxter.com/flows/manufacturing-packing-operators-31st-may-25-gqengvlfs EEO (Equal Employment Opportunity) This is where Baxter International Inc. is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Production Executive & operators injectables for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1. Vial Washing 2. Filling 3. Compounding 4. Lyophilization 5. Autoclave 6. Sealing 7. Monitoring of aseptic area / Environmental \ Media Fill \ Lyophilization operation The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to krishna_veni@mydashboards.in Thanks and Regards Krishnaveni - Dashboards Team HR

Greetings from Continental Hospital Hiring CSSD Technician Experience : 1 to 6 In hospitals, the Central Sterile Supply Department (CSSD) is responsible for ensuring the cleanliness, sterilization, and distribution of medical equipment and supplies . It plays a crucial role in preventing hospital-acquired infections and maintaining patient safety. Here's a breakdown of CSSD functions: 1. Cleaning and Decontamination: CSSD personnel receive soiled items from various departments and disassemble them. They utilize automatic washers and ultrasonic cleaners to ensure thorough cleaning and disinfection, following established protocols. Inspections are conducted to confirm that items are free of debris and contaminants. 2. Packing and Sterilization: Cleaned items are inspected, assembled, and packaged using appropriate materials and methods. Sterilization is performed using various methods, such as autoclaves or ethylene oxide, to eliminate all microorganisms. Sterilization is monitored using chemical and biological indicators to ensure its effectiveness. 3. Storage and Distribution: Sterilized items are stored in designated areas, maintaining their sterility until needed. CSSD provides a readily available supply of sterile equipment and supplies to various departments, including operating rooms, clinics, and emergency rooms. 4. Other Functions: CSSD may also handle the recycling of certain medical equipment and supplies. They play a vital role in controlling nosocomial infections by ensuring strict hygiene practices. CSSD staff work closely with other hospital departments to meet the demands of patient care.

A hospital and lab equipment's manufacturing company is looking for a Domestic sales officer , who should be very good in english communication , have prior experience in medical equipment sales in India . visit exibition and ready to travel Required Candidate profile we need two people for each machine Candidate should have prior exp in sales of Pharma machinery – Biosafety cabinet Phama machinery – Autoclave

Role & responsibilities Expertise in batch manufacturing and preparation related activities. To observe & follow all rules and regulations of the production department. Must be from Parenteral background & exposure to Aseptic vial / Bottle filling process is desirable. To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures. Technical exposure and expertise on filling & Autoclave machine. Exposure of USFDA audits. Preferred candidate profile Candidate should have relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization. Perks and benefits As Per Company Norms.

We are seeking a highly skilled and detail-oriented Quality Assurance (QA) Executive to join our esteemed pharmaceutical organization. The ideal candidate must have hands-on experience in Sterile Section operations and expertise in validation processes. This role offers an excellent opportunity to work in a dynamic and regulatory-driven environment within the pharmaceutical industry. Key Responsibilities: Sterile Section Experience: A minimum of 2 years of experience in the Sterile Section of a pharmaceutical company is mandatory. Validation Expertise: Proficient knowledge of validation procedures, including: HVAC Validation Autoclave Validation Sterilization Tunnel / DHS Validation BMR/BPR Review: Responsible for reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) before final submission. Aseptic Practices: Strong understanding of Dry Powder, Ampoule Section, and aseptic processing techniques. Temperature Mapping: Experience in temperature mapping and maintaining compliance with regulatory guidelines. Regulatory Compliance: Ensure adherence to GMP, regulatory requirements, and quality standards in all processes. Grooming Standards: The candidate must maintain a professional appearance with short hair and a clean-shaven look as per company policy. Key Skills & Requirements: 3-5 years working in pharma company. Strong knowledge of pharmaceutical quality assurance practices. 2 years of experience in Sterile Section of a pharmaceutical company is must ( ***2 years Sterile Section experience is a must ). Knowledge of Review of BMR/BPR before final Submission is required. Knowledge of Dry Powder, Ampoule Section and the Aseptic Practices is quint essential. Knowledge of Temperature mapping is required. Person should b having short hair and being clean shaven is must.

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 Division :- Formulation Interview Date:-05-04-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-V, RK Puram & Unit-II, Kothur Venue Location :- MSN Laboratories Pvt Ltd, Formulation Unit -II, Kothur Survey Nos.1277 & 1319 to 1324, Nandigama (Village), Kothur (Mandal, Mahbubnagar, Telangana 509001 MSN Laboratories Pvt Ltd,. Formulation Unit-02, Kothur, Nandigama. 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.

Alembic Pharmaceuticals is looking for Jr. Executive(Operator) - Manufacturing (Injectable) for our Formulation Unit-3, Karakhadi. Job Criteria: 1-7 years ITI/Diploma qualification Job Responsibility: Perform assembling as per defined procedure. Operate filling machine/ Ophthalmic/ PFS machine. Operate homogenizer. Perform batch filtration activity. Perform aseptic manufacturing activity. To unload steam sterilizer and bio-decontamination chamber in co-ordination with equipment preparation and sterilization area. To take part in area qualification activity. To take part in periodic area requalification activity. Aseptic area equipment qualification, filling machine qualification, media fill process. Interested candidates may share their resumes to " injectable@alembic.co.in "

Vacancy in Multiple Roles Sterile FRD & ARD Production Manager Operator (Production)-NASAL / Tablet/ Lotion Quality Control (AMV/ QMS/ Finish/ Stability/GLB/RM) Engineering (Electrical/Mechanical/ Utility/Water/CIVIL/ ETP) Logistic Receptionist PPIC

Pfizer Walk-in Drive at Vizag for Manufacturing roles Job Title: 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. Interview date & Time: Sunday, 13th April 2025 at 9:00 AM Venue: Hotel Best Western Ramachandra - Vizag # 8-8-36, GNT Rd, Medical Center, Gajuwaka, Visakhapatnam- 530026 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.

1. To review and implement Quality Management System for cGMP compliance at Production SVP plant. 2. To review and approval of BMR, BPR in Caliber BRM software. 3. Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, serialization & aggregation. 4. Giving the required training, also responsible for Media fill and GMP compliance. Handling of Quality Risk Management (QRM). 5. Responsible for Job allocation of Production Team. 6. To ensure the GMP at all level in the SVP plant. 7. To review and approval of production documentation for compliance with cGMP requirements. 8. To prepare & review SOPs, Validation Protocols, Master Batch Production Records and other related documents at Production SVP plant. 9. To review Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 10. Review signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical, APQR and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations. 11. To coordinate with warehouse team for ensuring the availability of raw material and packing material. 12. Ensure the execution of Process validation and equipment validation. 13. To review batch production Records, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated. 14. To conduct and monitor calibration, qualification, validation and requalification activity at site. 15. To ensure release (approval of rejection) the batch manufactured at site. 16. To review product License Application and support Regulatory department, obtaining the product license from the local Regulatory Authority. 17. To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 18. To inform top Management on quality issue (if any). 19. Ensure the compliance with online dispensing, manufacturing, filling, sealing, Visual Inspection and packing activities. 20. To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit in Production. 21. Participation and monitoring all activities of small volume parenteral (SVP) project in coordination with CFT like QA, QC, Engg and warehouse dept. 22. Review and approval of all documents pertaining to small volume parenteral facility. 23. Responsible for Aseptic behaviour in Aseptic area. Interested candidates can share their resme on dipika.parmar@milanlabs.com

Please find below details of the job opportunity: Department: Production (Sterile Manufacturing) Designation: Operator - Assistant / Associate Qualification: ITI/ Diploma / B.Sc Total Experience: 02 to 8 years (Pharma experience only) Job Locations: SEZ- Matoda (PHARMEZ), Ahmedabad Job Responsibility: Area: Aseptic & Controlled area operation (Filling, Sealing, filtration, Autoclave, Batch Manufacturing, terminal sterilization, Tunnel Operations, QMS Activities, packing etc.) Line: PFS, Lyophilizer and Vial, Bag Line, Emulsion Line Machine Exposure: filling machine (Groninger / Optima), Dyno Truking filling and sealing machine, Bosch filling machine, Steam sterilizer (Fedegree) Desired Profile: Expertise in batch manufacturing and preparation related activities. To observe & follow all rules and regulations of the production department. Must be from Parenteral background & exposure to Aseptic vial / Bottle filling process is desirable. To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures. Technical exposure and expertise on filling & Autoclave machine. Knowledge of change control, Deviation, CAPA, and documentation in manufacturing area of injectable. Knowledge of equipment validation and qualifications in injectable. Preparation & review of BMR-BPR Exposure of regulatory audits like USFDA/ TGA/ EU etc.. Kindly Note: We are having Virtual Interview Drive on 30th March, 2025 ( Sunday) Interested candidates can apply online on the below mentioned link https://forms.gle/krLe4X7emsUquCgm8 or share profile at pranjali.raval@amneal.com