102 Sterile Jobs - Page 4

Greetings from Pulse HR Consultants! We are having urgent openings in the leading Injectable Pharma Industry at Hyderabad location for the below positions Production Department. 1. Technical Assistant / Sr. Technical Assistant -Production injectables Diploma/ B.Sc. with 2 to 9 years Compounding, vial wash/filling, Autoclave, Washing, Filling, Sealing, Batch Manufacturing, Lyophilization Operation, PFS , Ophthalmic 3 piece, BFS & Infusion BAG filling operations. 2. Executive /Sr. Executive-Production Injectables B.Pharma with 2 to 8 years experience in Autoclave, Washing, Filling, Sealing, Batch Manufacturing, Lyophilization Operation, PFS , Ophthalmic 3 piece, BFS & Infusion BAG filling operations. Please share and refer to info@pulsehr.org / pavani@pulsehr.org

Job Description Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 1-12 years above in production, preferably in the Bio-Pharmaceutical industry, specifically in vaccine manufacturing Educational Qualification: MSc Microbiology/Biotechnology/B. Pharm/B.Tech with more than 8 years of experience in vaccine biologicals and injectables Job Title: Senior Manager / Manager / Executive- Production Job Summary: The Senior Manager /Executive - Production will oversee daily vaccine manufacturing operations, ensure compliance with regulatory guidelines, manage production staff, and drive continuous improvement to enhance operational efficiency and product quality within the pharmaceutical industry. Key Responsibilities: Production Planning and Coordination: Plan, coordinate, and optimize end-to-end vaccine production activities to meet quality standards, timelines, and cost targets while ensuring resource availability. Oversee Manufacturing Operations: Supervise day-to-day manufacturing operations, including formulation, filling, packaging, and storage processes, ensuring efficient workflow and compliance with production protocols. Compliance: Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory guidelines (FDA, EMA, WHO). Issue Resolution: Troubleshoot and resolve production-related issues to minimize downtime and ensure batch integrity. Team Management: Lead and manage production staff, providing training on safety, quality, and operational protocols specific to vaccine manufacturing. Performance Monitoring: Track key production metrics, implement strategies to improve batch yields, and reduce material wastage. Safety Enforcement: Enforce workplace safety protocols to prevent accidents, contamination, and ensure bio-safety compliance. Risk Management: Identify risks in production processes, such as contamination risks or equipment failures, and develop contingency plans. Material Handling: Ensure safe handling, storage, and disposal of biological materials, vaccines, and hazardous chemicals following industry best practices. Process Improvement: Drive continuous improvement initiatives to enhance production efficiency and product quality. Equipment Management: Oversee the maintenance, calibration, and validation of production equipment to ensure optimal performance. Documentation and Reporting: Ensure accurate documentation of production activities and prepare reports for regulatory compliance and internal audits. Skills and Competencies: Strong leadership and team management abilities in vaccine manufacturing environments In-depth knowledge of GMP, regulatory compliance, and vaccine production protocols Proficient in production planning, batch processing, and process optimization Excellent problem-solving and troubleshooting skills within pharmaceutical production settings Strong communication and interpersonal skills for effective team coordination Risk assessment and mitigation capabilities specific to biological production Commitment to bio-safety, product quality, and continuous improvement About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company dedicated to delivering quality healthcare solutions, with a strong focus on vaccine manufacturing and biological products. Our commitment to innovation, compliance, and operational excellence drives our success. For more information, please visit our website: www.gsbpl.com How to Apply: Interested candidates can apply at: hr@gsbpl.com Contact us at: 8778926365 Apply Now to join our team and contribute to impactful pharmaceutical and vaccine innovations!

Job Title: Executive / Manager/Senior Manager Quality Control Department: Quality Control (QC) Company: Greensignal Bio Pharma Pvt Ltd Location: Gummidipoondi, SIPCOT, Chennai Position Overview: The Manager/Senior Manager of Quality Control (QC) at Greensignal Bio Pharma Pvt Ltd is responsible for developing, implementing, and managing quality control strategies and activities. This role ensures that all quality control processes are compliant with industry regulations and align with organizational goals. The individual will lead various quality control activities, such as sampling, testing, inspection, and documentation, while ensuring compliance with regulatory standards. Key Responsibilities: Develop and implement quality control strategies that align with organizational goals and regulatory standards (e.g., FDA, EU, WHO). Collaborate with cross-functional teams to ensure alignment of quality control objectives across departments. Oversee quality control activities, including sampling, testing, inspection, and documentation, ensuring compliance with internal and external standards. Ensure all quality control activities meet required regulatory standards (e.g., FDA, EU, WHO), and implement corrective actions when needed. Develop, maintain, and review quality control procedures, policies, and documentation to ensure consistency and compliance. Conduct internal audits to evaluate compliance with quality control procedures and identify areas for improvement. Collaborate with the regulatory affairs team to ensure timely and accurate submission of quality control documentation for regulatory filings. Provide training, guidance, and coaching to team members, ensuring they possess the necessary skills to perform quality control tasks effectively. Communicate quality control results, non-conformances, and corrective actions to cross-functional teams in a timely manner. Identify opportunities for continuous improvement in quality control processes and implement initiatives to improve efficiency and compliance. Minimal Qualifications: Education: Masters degree in Microbiology, Life Sciences, Pharmacy, or a related field (M.Sc. Microbiology preferred). Experience: Minimum of 8 years of experience in quality control, preferably in the pharmaceutical or biotechnology industry. Knowledge: Strong understanding of regulatory requirements (e.g., FDA, EU, WHO), microbiology, instrumentation, EMP, failure investigation, and related documentation. Skills: Excellent leadership and project management abilities. Strong written and verbal communication skills. Ability to collaborate effectively with cross-functional teams. Preferred Qualifications: Experience with global regulatory filings and compliance audits. Certification in Quality Management Systems (e.g., ISO 9001, Six Sigma). Expertise in advanced microbiological testing techniques. Personal Attributes: Strong problem-solving skills with keen attention to detail. Proactive and able to thrive in a fast-paced, dynamic environment. Ability to motivate, inspire, and develop team members. To Apply: Please submit your resume and cover letter detailing your qualifications and experience to the following contact details: Email: hr@gsbpl.com Mobile: 8778926365

Company: SAVA Healthcare is amongst the fastest emerging pharmaceutical company in India with global reach to customers in Canada, Ukraine and the CIS, Asia, Latin America, Africa & FWA. With manufacturing units in Surendranagar, Malur and in near future in Indore holds various accreditations and produces wide variety of dosage forms across therapeutic categories. Our GMP compliant, State of Art manufacturing facility for Tablet, Oral Dry Powder, Capsule, Nasal sprays, DPIs, Cream, Gel and Ointment formulations with dedicated manufacturing sections supported by In-House R&D Center, focuses on Formulation and Analytical Development with an annual turnover of more than 200 crores and manpower of 500+ employees engaged across locations. Job Location: Surendranagar Plant Job Summary: Production Management: Supervise and coordinate the activities of the production team to meet production schedules and targets. Ensure efficient use of resources and equipment to maximize productivity. Monitor production processes and adjust schedules as needed to meet changing demands. Quality Assurance: Ensure all production activities comply with GMP (Good Manufacturing Practices) and FDA regulations. Conduct regular inspections and audits to ensure adherence to quality standards. Address and resolve any quality issues that arise during production. Process Optimization: Identify areas for improvement in production processes and implement changes to enhance efficiency and reduce waste. Utilize lean manufacturing principles and other continuous improvement methodologies. Collaborate with the engineering and quality assurance teams to optimize equipment performance and product quality. Team Leadership: Lead, train, and mentor production staff to ensure they have the skills and knowledge required to perform their duties effectively. Conduct performance evaluations and provide feedback to team members. Foster a positive and collaborative work environment. Documentation and Reporting: Maintain accurate and up-to-date records of production activities, including batch records, logbooks, and production reports. Prepare and submit regular reports on production performance, including output, efficiency, and quality metrics. Ensure all documentation is compliant with regulatory requirements. Compliance and Safety: Ensure all production activities are carried out in compliance with safety regulations and company policies. Conduct regular safety training and drills for production staff. Investigate and report any accidents or incidents in the production area. Inventory Management: Monitor inventory levels of raw materials, packaging materials, and finished products. Coordinate with the procurement department to ensure timely availability of materials required for production. Implement inventory control measures to minimize stockouts and excess inventory. Qualifications: Bachelors degree in Pharmacy, Chemistry, Engineering, or a related field. A minimum of 3-5 years of experience in pharmaceutical manufacturing or a similar production environment. Strong knowledge of GMP, FDA regulations, and pharmaceutical manufacturing processes. Proven experience in managing production teams and processes. Excellent problem-solving skills and the ability to make quick decisions. Strong organizational and time management skills. Proficiency in using production management software and tools. Effective communication and leadership skills.

Operate production equipment such as injectable machines, sterile machines, parenteral machines, formulation machines, filling machines, capping machines, compounding machines, washing machines, and sealing machines. 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.

Role & responsibilities Responsible for Drup Product Manufacturing Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities. Filling line in built CIP, SIP operations Knowledge of Isolator VHP, Blending vessels- CIP, SIP Good at QMS Regulatory inspection exposure WHO-PQ, USFDA, EU GMP, TGA,ROW Experience in O RABS, Isolator filling lines Lyophilizers - ALUS, Manual operations Blending of viral, bacterial vaccines Media fill activities , TRS 1044 updates Responsible for preparing production plan in consultation with PPIC department and execution thereof with effective planning and utilization of Men, Materials and Machineries for quality linked productivity. To approve the instructions relating to production operations and to ensure their strict implementation. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To ensure that the production records are evaluated and signed by an authorized person. Review investigation of Quality Management System (QMS) including market complaint, Out of Specification (OOS), change controls of manufacturing, risk assessment, Corrective Action and Preventive Action (CAPA) etc. To ensure the qualification and maintenance of department, premises and equipment. Ensure compliance to master formula and process provided in the Batch Manufacturing Record (BMR). To ensure that the appropriate validations are done. Reviewing document like of Standard Operating Procedures (SOPs), Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR)etc. and compliance reports thereof with training of personnel on the same. Ensure appropriate inventory of Consumable in the Department for smooth functioning. Responsible for Co-ordination with Technical Services, Quality Assurance / Quality Control, Finance, Purchase, Warehouse and Administration Departments for effective management of Production targets. Ensure wastage control and optimization of yield at various stages of manufacturing and packaging operations. Ensure compliance to various In-process control guidelines provided in the batch documents. Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance. Ensure that personnel follow basic safety guidelines during operations. Responsible for the preparation of training calendar for employees and to ensure that the required initial and continuing training of department personnel is carried out and adapted according to need on cGMP and various operational activities. Responsible for preparation of accurate and timely reports of various production activities showing performance and shortcomings against agreed/planned parameters (monthly presentation, work in progress (WIP) statement yield report, monthly planning, expense budget stationary, housekeeping material, production item &capital budget etc). Preferred candidate profile M.Pharm/ B.Pharm / MSc ; Experience- 18 to 25 years Candidate Must have exposure of regulatory Audits should be willing to relocate with family to ahmedabad

Manufacturing of lyophilized product, liquid injection, Liposome, microsphere product and filling activities of Lyophilized vial, Liquid vial, PFS, Cartridges, Glass ampoule Preparation and review of documents like product BMR, media fill BMR, PVP,

Hiring for IPQA in QA Department with experience of sterile or injectables plant only salary - 7.5LPA Qualification - B.Pharma/M.Pharma Location - Baddi, Himachal Interview Mode - first virtual Intrested candidates share resume on 98156-75900

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 spectrometer etc., and ability to operate them effectively.

Job description SUMMARY OF THE JOB To lead a ground of product development team. Product development for US, Russia & Europe market Improvement of current products for Russian market. Development of Herbal products for Indian & Russian market. Technology transfer of new products to manufacturing locations. Technology transfer support for the products to be transferred from one location to other location. To provide support to regulatory department in dossier filing. Para IV possibilities for ophthalmic products. GMP/GLP compliance of product development department. To conduct training and upgrade soft skills of formulators in product development. To identify training needs of subordinates and provide training to them. To identify needs for product development department in terms of equipment and procure them. KEY FUNCTIONS / RESPONSIBILITIES Project initiation activities:- To understand project timelines and required activities for the timely execution. To perform literature search required for idea generation form (IGF) upon receiving IGF. To review DMF received from suppliers. To prepare product feasibility based on IGF received. To create the item codes for material and procure material and Reference Listed Drug (RLD). To assist AD lab for Q1 Q2 estimation of RLD. To draft tentative specification for API, RM and finished good. To plan laboratory trials and stability batches. To finalize proposed manufacturing process. To initiate filter validation process with the filter supplier. To handle Bead mill and high pressure homogenizer Documentation:- To prepare tech transfer documents including MFR, BOM, Process flowchart, Critical process parameters and critical quality activities. To review product specifications, manufacturing documents. To prepare documents for trial batches. To prepare product development report. To prepare and review SOPs and prepare response for internal audits. To review documents related to filter validation. Product Specification/ Tech Transfer/ Commercialization To organize and execute trial pre exhibit and exhibit batches at plant. To execute first three commercial batches at plant. To provide technical support for existing commercial batch. To perform investigation of failures during exhibit batches/ stability (Out of Specification). Innovation To come up with innovative and patentable formulations proposals. To come up with novel ideas which can reduce workload or expenses. Train, mentor and supervise RA To mentor RAs in planning the project activities in minute and actionable details. Help RAs in carrying out literature search. Help RAs in carrying out procurement of RLD, API and excipients. Plan and execute Knowledge sharing session for compatibility studies, reverse engineering, laboratory batches planning, filter compatibility, process optimization and recent updates in the field to emphasize importance of timeline adherence to team members

Crystalline Manager Production for the distribution of the instructions and producing API’s/intermediate as per production plan.This includes responsibility for safety,cleanliness of system during product change over or after non/production activity

Job Title : QC(HPLC) Job Location : Sonipat, Haryana. Experience: 3+ Years. (API companies is preferred) Interested candidates can share their resume at hrcdpl-4@coraldrugs.com or WhatsApp resume@8199986208

Biological E. Limited invites dynamic & self-motivated fresher candidates for Production department at its Pharma SGI - Injectables USFDA Approved plant, Shamirpet, Hyderabad: Desired Candidate Requirements: Good communication skills Able to work in shift operations (A,B & C) B.Sc & Diploma passed in 2024 & 2025 with > 60% marks Learning apatite Confidence Prepared male candidates

Greetings! We are looking for Formulation Research & Development Scientist - Injectables for a leading Pharmaceutical company based at Chennai location. Interested Candidates Kindly share your updated cv to srinidhi@bvrpc.com

Role & responsibilities > Should have experience on injectables process maintenance. > Preventive maintenance and breakdown maintenance on Vial Filling, Tunnel, Vial Washing, Lyophillizer, Autoclave, Capping. > Must be from Injectable plant.

Roles and Responsibilities: Expertise in Compounding, Aseptic Operations, and Equipment Troubleshooting with a focus on solution-oriented approaches. Dry Powder Filling/Autoclave Operators/ Vial Sealing/ Line Chemist/ Compounding Chemist. Vial Washing, Ampoules, PFS, Bag & Filling & Sealing Operators. ANDA Projects & QMS activities (FCR, DCR, BPCR Preparation, SOP Preparation & Track-wise related knowledge). Compounding and filtration of the product as per batch manufacturing records & ensuring the cleanliness of the compounding area, personal entry and material pass of the component area, and APA & online documentation.

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 khyati@bvrpc.com

Walk-in at Matoda We are hiring multiple positions for our manufacturing facility at Matoda 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. Role & responsibilities QUALITY ASSURANCE IPQA (Injectable), IPQA (OSD) & QMS / Documentation / Validation and Qualification (Officer / Senior Officer / Executive/Senior Executive) Experience - 02 to 09 Years Qualification - B. Pharmacy/ M Pharmacy / M.Sc. Injectable Manufacturing Aseptic operations/ QMS / SKID / Multi-vessel / SVP / Visual Inspector (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification - B. Pharmacy/ M Pharmacy / Msc /Bsc / Diploma / ITI OSD Manufacturing / Dispensing / QMS (Senior Officer / Officer / Associate) Experience - 01 to 05 Years Qualification B Sc / M Sc / B. Pharmacy/ M Pharmacy / Diploma Time and Venue : 17th May 2025, 09:30 Hrs to 14:00 Hrs SATURDAY ______________________________________________________ INTAS, Matoda facility Plot No. 457, 458 Sarkhej Bavla Highway, Matoda Village, Sanand, Taluka, Ahmedabad, Gujarat 382210 ______________________________________________________ We would be pleased if you forward or refer any of your colleagues matching the desired job roles. Preferred candidate profile *Having relevant qualification as mentioned above can attend the scheduled walk-in.

Roles & responsibilities: Media preparation, media suitability test, growth promotion test. Water sampling and testing. Maintenance of stock cultures, sub culturing and culture suspension preparation. Environment monitoring program (passive air sampling, Active air sampling and surface sampling). Sterility Testing, Bacterial endotoxin test, bioburden testing. Testing of Total organic carbon (TOC) in water samples. Endotoxin testing through KTA method and Gel Clot method. Testing of media fill samples. Enumeration of biological indicators. Preparation of trends and compilation summery for water and environmental monitoring. Establishment of alert and action limits for water and environmental monitoring. Establishment of Limit for bioburden samples. Identification or microorganisms by Vitek 2 Identification system. Container closure integrity test. Preservative efficacy test. Disinfectant Validation. Handling of Change controls, deviation, Out of Specification and writing of audit justification reports. Preparation of sops, protocols and reports aligning as per quality standards, cGMP documents as per pharmacopeias. Audits faced USFDA,WHO, MHRA, ANVISA,customer audits, etc.. Training of team members in SOP, Analyst qualification, Quality documents Preferred candidate profile: Posses the quality of good Team Leader. Believe in team work. • Should have exposure to day-to-day routine microbiological activities like media preparation, culture handling, Plating etc. *Relevant experience must be for working in microbiology lab. *Must have experience of working into sterile area.

Job Description : - Department - Injectable Mfg & Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 6 Education - ITI / Diploma Eng / D.Pharma / B.Pharma / M.Pharma Skill Set - Require good knowledge in Complex Skid / NDDS / Aseptic (PFS / Vials Liquid) / Autoclave/ Lyopholizer / Batch Manufacturing, Sterile Secondary Packing and track and trace activity + visual inspection activity. Department - QC ( QC FG / Stability / AMV ) Position - Officer to Executive Exp - 2 to 7 Education - M.Sc / B.Pahrma / M.Pharma Skill Set - Analyst : Finished, AMV & Stability Section. knowledge of Instrument - HPLC / GC. Preferably know-how of Chromeleon Software Department - Engineering ( Plant Maintenance Sterile / Instrumentation Sterile ) Exp - 2 to 15 Position - Technician / Executive / Assistant Manager / Manager Education - Diploma Eng / ITI / B.Tech Skill Set - Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility Department - QA ( IPQA / Qualification (Sterile Background Only) Position - Officer to Executive Exp - 2 to 7 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Have good exposure in Sterile IPQA & Sterile Qualification Related activity Department - Lab QA Position - Officer to Sr. Executive Exp - 2 to 9 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Having good exposure of QC QMS handling , Lab instrumentation & audit trails. Have strong background of Lab QA activity. Department - Solid Oral Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 5 Education - ITI / Diploma Eng / D.Pharma / B.Pharma Skill Set - Require good knowledge in Primary & Secondary Packing, Track & Trace, Carton Packing Machine (CAM HV1 Model), Online Documentation BPCR / Logbook etc.

Key Responsibilities: Oversee end-to-end manufacturing operations for Nasal formulations (sprays, drops, etc.). Ensure adherence to production schedules, batch planning, and resource allocation. Monitor and enforce cGMP, safety, and hygiene practices across the Nasal production area. Review and maintain production documentation including BMRs, BPRs, and SOPs. Coordinate with Quality Assurance, Quality Control, Engineering, and Warehouse for seamless operations. Identify and troubleshoot production issues to minimize downtime and rejections. Lead a team of operators and supervisors, ensuring proper training and performance monitoring. Participate in internal and external audits; ensure timely CAPA implementation. Drive process improvement initiatives to increase productivity and reduce waste. Ensure proper maintenance and calibration of production equipment used in Nasal manufacturing.

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Help in Day To Day Production Of Pharmaceutical Products Manpower Allocation For Smooth Working In Shift Supervision Of Production Activity BMR And BPR Report Preparation Data Preparation For Internal And External Audit -IE. US FDA - EU GMP Etc Required Candidate profile B. Pharm - M. Pharm - B.Sc - M. Sc Experience In Production Or Packaging Working Experience US FDA Approved Plant is Desirable FDA Approval in Tablet - Capsule Or Any will be an added advantage

Sterilization and Decontamination: Cleaning, decontaminating, and sterilizing medical instruments, equipment, and supplies using various methods like autoclaving. Equipment Operation and Maintenance: Operating and maintaining autoclaves, low-temperature sterilizers, and other sterilization equipment, ensuring proper functioning and adherence to safety protocols. Instrument Inspection: Inspecting instruments and supplies for cleanliness, proper function, and any defects before they are sterilized. Assembly and Packaging: Assembling and packaging sterile instruments and supplies in appropriate containers or trays for storage and distribution. Inventory Management: Maintaining accurate inventory records of sterile supplies and instruments, ensuring adequate stock levels. Distribution: Providing sterile supplies and instruments to various departments within the hospital or healthcare facility as needed. Documentation: Maintaining detailed records of sterilization processes and quality control measures, ensuring compliance with regulations. Collaboration: Collaborating with other healthcare staff, such as surgeons and nurses, to ensure timely availability of sterile supplies and address any needs.

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.