Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
Ahmedabad
INR 6.15 - 7.707 Lacs P.A.
On-site
Part Time
Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements. Qualification: B.Pharm/M.Pharm candidate with minimum 3-5 years experience in manufacturing QMS/Process review/Compliance.
Ahmedabad
INR 6.15 - 7.707 Lacs P.A.
On-site
Part Time
Responsible for document management like BMR’s, BPR’s, master SOP’s etc. Responsible for preparation & review of the master documents of production. Responsible to ensure UAF working in area. Responsible for the handling of change control, deviations, investigation & CAPA, etc Responsible to give training to all the subordinates, technicians and operators of the department. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. Responsible for line clearance activity before commencing the operations. Responsible to check that all the records and logbooks related to aseptic manufacturing, vial filling and vial sealing machine. Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department. Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area. Responsible for monitoring all the activities related to General, Control & Aseptic area. Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue. Responsible to ensure scheduled activity of respective area/equipment/instruments. Responsible to attend training as per schedule and to ensure training and work as per TNI. Follow the cGMP, Good Document Practice and discipline in the Company Premises. Qualification: M.Pharm./ B.Pharm./ M.Sc. Exp.: 3-7 years Candidate shall have experience in the Manufacturing of Injectable Products
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Responsible for document handling, issuance, distribution, and retrieval of docume,verification of documents like Batch Manufacturing records, Batch Packaging Records, Protocols, layouts, specifications, Method of Analysis, Logbooks, Planner, etc. Responsible for issuance of approved Standard Formats and Logbooks to User Departments, Issuance of line-clearance checklist, interventions checklist and additional pages of BMR/ BPR as requested by user, reconciliation, retrieval and archival of issued standard formats and logbooks. To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system Qualifications B.Sc / M.Sc / B.Pharm / M.Pharm Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system Qualifications M.sc / B.pharm / M.pharm Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Responsibility JOB DESCRIPTION 1 Responsible for preparation of packaging planning on monthly and also daily as per the requirement and availability of materials. 2 Responsible to update on self-hygiene. 3 Responsible to attend the training as per training schedule and to ensure the training as per TNI. 4 Responsible to work as per standard operating procedures, in general area of sterile manufacturing department. 5 Responsible for preparation, review, revision, control and implementation of Standard Operating Procedures of General Area in Sterile Manufacturing Department. 6 Responsible for BPR Preparation. 7 Responsible to ensure that all equipments and lines are in validated and calibrated status. 8 Responsible to check that all the records and log books related to general area and equipment of packaging, inspection area. 9 Responsible to give training to all the subordinates, technicians and operators of the department. 10 To follow the cGMP, Good Document Practice and discipline in the department. 11 Responsible for document handling of Packing, and Inspection. 12 Responsible for monitoring of all the activities related to packing, and inspection. Qualifications Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 2 - 7 Year in sterile manufacturing plant Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Site survey and plotting of layout as per drawings. Interpretation of plans and specifications. Monitoring architectural, structural and finishing work execution as per drawings Monitoring work progress, quality, and compliance with building codes and regulations. Prepare and track schedules, ensure timely completion of project. Contractor management, bill checking as per tender BOQ. Co-ordination with seniors, contractors, and other professionals to meet the project outcomes. Preparing and sending daily progress report. Work with cross functional teams for timely completion. Monitoring Quality of works as per IS Inspects materials and judge work quality for conformance with contract Testing on site of materials as per ITP and QAP. Knowledge of safety practices, permits and norms. Knowledge of AutoCAD, civil estimation, MS Project/Primavera, and QA/QC protocols. Knowledge of cleanroom panels, cGMP practices, different type of finishes in pharma industry. Show more Show less
Mumbai, Maharashtra, India
Not disclosed
On-site
Full Time
Key Responsibilities JOB DESCRIPTION Scientific & Medical Expertise Serve as a subject matter expert in neuroscience, providing high-quality scientific and medical support to internal and external stakeholders. Stay updated on the latest scientific advancements, treatment guidelines, and competitive landscape in neuroscience. Provide scientific training to internal teams, including commercial and market access teams. Stakeholder Engagement & Medical Communication Develop and maintain strong relationships with Key Opinion Leaders (KOLs), healthcare professionals (HCPs), and academic institutions. Lead scientific discussions and advisory boards to gather insights and address unmet medical needs. Deliver presentations at medical and scientific meetings, congresses, and symposia. Medical Strategy & Evidence Generation Contribute to the development and execution of the Medical Affairs Plan for neuroscience. Collaborate with cross-functional teams to provide medical input into brand strategies and regulatory submissions. Compliance & Ethical Standards Ensure all medical activities align with company policies, industry regulations, and ethical guidelines. Review promotional and non-promotional materials for scientific accuracy and compliance with regulatory standards. Key Requirements Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Scientific Knowledge: Strong understanding of neuroscience disease areas, treatment landscapes, and clinical data interpretation. Stakeholder Engagement: Experience in engaging with KOLs, HCPs, and scientific societies. Communication Skills: Excellent written and verbal communication skills, with the ability to translate complex scientific data into meaningful insights. Regulatory & Compliance Knowledge: Familiarity with local and global regulatory frameworks (e.g., ICH-GCP, FDA, EMA, DCGI guidelines). Qualifications Education: MD, BDS, PhD, or PharmD preferred (MSc or MBBS with relevant experience may be considered). Experience: Minimum 2 years of experience in Medical Affairs or a related role in the pharmaceutical industry, preferably in neuroscience. Show more Show less
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 6.0 - 12.0 Lacs P.A.
Work from Office
Full Time
To perform qualitative and quantitative analysis of raw materials and packaging materials In-process and Finished product as per applicable pharmacopeial standards, regulatory requirements, and internal specifications. Ensure timely release and compliance of materials to support uninterrupted manufacturing operations of injectable products. Essential Functions: Perform testing of raw materials (APIs, excipients) and primary/secondary packaging materials as per approved specifications, SOPs, and pharmacopeial methods (USP, EP, IP, JP, etc). Ensure accurate and timely recording of results in logbooks, worksheets, and LIMS as per Good Documentation Practices (GDP). Adhere to cGMP, GLP, and safety protocols during sample handling, testing, and equipment usage. Performing qualification, periodic calibration, and maintenance of laboratory instruments. Maintain proper cleanliness, calibration, and qualification status of analytical instruments. Coordinate with warehouse and QA for sampling of incoming materials as per SOPs. Ensure proper labeling, storage, and disposal of samples and reference standards. Support internal, customer, and regulatory audits by providing required documentation and clarifications. Implement corrective and preventive actions (CAPA) as per audit observations. Additional Responsibilities: Participate in method validation, verification, and transfer activities as required. Assist in updating and reviewing SOPs, specifications, and analytical procedures. Contribute to continuous improvement initiatives in the QC department. Report any out-of-specification (OOS) or out-of-trend (OOT) results promptly to the supervisor. Support cross-functional departments such as QA, Production, and Regulatory Affairs as needed.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 3.0 - 7.0 Lacs P.A.
Work from Office
Full Time
Amneal Pharmaceuticals is looking for Officer, Quality Control to join our dynamic team and embark on a rewarding career journey A Quality Control Professional is responsible for ensuring that products or services meet established quality standards and customer expectations They play a vital role in maintaining and improving the quality of products, processes, and systems within an organization The specific job duties may vary depending on the industry and organization, but here are some common responsibilities:Quality Assurance: Develop and implement quality control procedures and policies to ensure compliance with regulatory requirements and industry standards This involves creating quality control plans, conducting risk assessments, and establishing quality metrics Inspection and Testing: Perform inspections, tests, and sampling procedures to assess product quality and identify any deviations from standards This may include visual inspections, measurements, functional testing, and other specialized techniques They analyze test data and generate reports to document findings Process Improvement: Collaborate with cross-functional teams to identify areas for process improvement They participate in root cause analysis investigations to determine the underlying causes of quality issues and implement corrective actions to prevent reoccurrence Documentation and Reporting: Maintain accurate and detailed records of quality control activities, test results, and other relevant documentation They prepare quality reports, summaries, and presentations to communicate findings to management and stakeholders Training and Compliance: Provide training and guidance to employees on quality control procedures, standards, and best practices They ensure that employees understand and follow quality guidelines and regulatory requirements They also monitor compliance with internal quality policies and external regulations Supplier Quality Management: Collaborate with suppliers to establish quality requirements and monitor supplier performance They conduct supplier audits, evaluate incoming materials or components, and address any quality issues with suppliers Continuous Improvement: Stay updated on industry trends, emerging technologies, and regulatory changes related to quality control They actively seek opportunities for continuous improvement and implement new methodologies or tools to enhance quality control processes
Hyderabad, Telangana
Not disclosed
On-site
Full Time
Responsible for in process Quality Assurance activities Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOP's Good Documentation recording and updation Responsible for Preparation and Implementation of SOP's. Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Responsibilities other than defined in the JD are to be done as per instruction of HOD Bachelor's Degree in Pharmacy, Microbiology, Biotechnology, Chemistry, or a related field. Master's Degree in Quality Assurance, Regulatory Affairs, or a related field (preferred but not mandatory). 3-5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry. Hands-on experience with GMP inspections , environmental monitoring , and aseptic process simulations . Proven track record in sampling . Experience in reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) . Familiarity with SOP preparation and implementation . Involvement in change control , deviation management , and failure investigations .
Ahmedabad
INR 2.0 - 6.5 Lacs P.A.
On-site
Part Time
Maintain up-to-date launch trackers (covering OSD, Injectable, Ophthalmic, and CMO projects) Coordinate with India cross-functional teams (CFTs) Manage the introduction of new product forms and trade dress readiness Attend NPL meetings and sharing minutes of meetings (MoMs) Prepare presentations for tracking and reporting purposes Coordinate for JDE set up process, COGS calculation, and serialization activities Follow up on all action items from the meetings and ensure all action items are closed in a timely manner Provide real-time updates on API, materials, and packaging component status Track manufacturing, packaging, and release status for NPLs Follow up on stability sample delivery, chamber charging, and analysis for site transfer projects Collaborate with Regulatory Affairs on CBE-30 and PAS filing documents Communicate across all stakeholders and upper management to inform on the project status, critical path items, risks, and delays, if timeline does not meet Complete transport request forms for upcoming launches and track the shipment Good communication and negotiation skills Master's Degree / Bachelor's Degree Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Ahmedabad
INR Not disclosed
On-site
Part Time
Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible to perform the environment monitoring activities Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of executed BMRs and BPRs. Responsible to perform the in-process test at different stages as per batch document/SOP. Responsible to review the environment monitoring, water trends. Responsible to review the different type of planner and calibration certificates. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. Responsible to monitor cGMP compliance at shop floor. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Responsible to participate in perform qualification activities of manufacturing area. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Review of Visual inspector qualification record. Education: B.Sc./ M.Sc in Microbiology Total Experience 7-10 Year inexperience in Environmental Monitoring for sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.
Hyderābād
INR Not disclosed
On-site
Part Time
Responsible for in process Quality Assurance activities Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOP's Good Documentation recording and updation Responsible for Preparation and Implementation of SOP's. Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Responsibilities other than defined in the JD are to be done as per instruction of HOD Bachelor's Degree in Pharmacy, Microbiology, Biotechnology, Chemistry, or a related field. Master's Degree in Quality Assurance, Regulatory Affairs, or a related field (preferred but not mandatory). 3-5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry. Hands-on experience with GMP inspections , environmental monitoring , and aseptic process simulations . Proven track record in sampling . Experience in reviewing Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) . Familiarity with SOP preparation and implementation . Involvement in change control , deviation management , and failure investigations .
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Responsibility JOB DESCRIPTION Responsible to update on self-hygiene. Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department. Responsible for preparation & review of the master documents of production. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible for operations like manufacturing, filling & sealing, labeling and packing operations. Responsible for preparation of production planning on monthly and also daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to ensure that all equipment and lines are in validated and calibrated status. Responsible to follow cGMP, GDP and discipline in the department and to ensure that all employees follow the same. Responsible to check that all the records and log books related to manufacturing, washing, filling, sealing and sterilization of equipment. Responsible to give training to all the subordinates, technicians and operators of the department. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. Responsible to attend the training as per training schedule and to ensure training as per TNI. Responsible to maintain the facility in compliance manner and keep the area ready of inspection. Qualifications Education: B.Pharma, M.Pharma Total Experience - 15 - 18 Year in sterile manufacturing plant Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements. Qualifications Qualification: B.Pharm/M.Pharm candidate with minimum 3-5 years experience in manufacturing QMS/Process review/Compliance. Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Responsible to participate in perform qualification activities of manufacturing and Microbiology area Responsible for Compressed air /nitrogen gas monitoring and Personnel monitoring. Planning and execution for environmental monitoring of manufacturing and microbiology lab clean room area as per the defined schedule Planning of compressed air /nitrogen gas monitoring and personnel monitoring. To perform calibration/qualification of instruments/equipment as per predefine schedule. Responsible to participate in media fill simulation study. Handle sterility testing, Handling of microbial identification, Handling of bacterial endotoxin test Qualifications Qualification: B.Sc./M.Sc./B. Pharm Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Maintain up-to-date launch trackers (covering OSD, Injectable, Ophthalmic, and CMO projects) Coordinate with India cross-functional teams (CFTs) Manage the introduction of new product forms and trade dress readiness Attend NPL meetings and sharing minutes of meetings (MoMs) Prepare presentations for tracking and reporting purposes Coordinate for JDE set up process, COGS calculation, and serialization activities Follow up on all action items from the meetings and ensure all action items are closed in a timely manner Provide real-time updates on API, materials, and packaging component status Track manufacturing, packaging, and release status for NPLs Follow up on stability sample delivery, chamber charging, and analysis for site transfer projects Collaborate with Regulatory Affairs on CBE-30 and PAS filing documents Communicate across all stakeholders and upper management to inform on the project status, critical path items, risks, and delays, if timeline does not meet Complete transport request forms for upcoming launches and track the shipment Good communication and negotiation skills Qualifications Master's Degree / Bachelor's Degree About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Responsible for document management like BMR’s, BPR’s, master SOP’s etc. Responsible for preparation & review of the master documents of production. Responsible to ensure UAF working in area. Responsible for the handling of change control, deviations, investigation & CAPA, etc Responsible to give training to all the subordinates, technicians and operators of the department. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance. Responsible for line clearance activity before commencing the operations. Responsible to check that all the records and logbooks related to aseptic manufacturing, vial filling and vial sealing machine. Responsible for preparation, review, revision, control and implementation of standard operating procedures of sterile manufacturing department. Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area. Responsible for monitoring all the activities related to General, Control & Aseptic area. Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue. Responsible to ensure scheduled activity of respective area/equipment/instruments. Responsible to attend training as per schedule and to ensure training and work as per TNI. Follow the cGMP, Good Document Practice and discipline in the Company Premises. Qualifications Qualification: M.Pharm./ B.Pharm./ M.Sc. Exp.: 3-7 years Candidate shall have experience in the Manufacturing of Injectable Products Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Person having minimum experience of analysis and processing of In process and Finished product and handling of HPLC,UV,FTIR,K/F,AAS,IC,Dissolution (Sotax) and other instruments Qualifications Qualification: Master's degree preferred (M.sc/ M.pharm / B.Pharm) Experience: 2-4 years Person having minimum experience of analysis and processing of In process and Finished product and handling of HPLC,UV,FTIR,K/F,AAS,IC,Dissolution (Sotax) and other instruments Show more Show less
Ahmedabad, Gujarat, India
Not disclosed
On-site
Full Time
Job Description Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible to perform the environment monitoring activities Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of executed BMRs and BPRs. Responsible to perform the in-process test at different stages as per batch document/SOP. Responsible to review the environment monitoring, water trends. Responsible to review the different type of planner and calibration certificates. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. Responsible to monitor cGMP compliance at shop floor. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Responsible to participate in perform qualification activities of manufacturing area. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Review of Visual inspector qualification record. Qualifications Education: B.Sc./ M.Sc in Microbiology Total Experience 7-10 Year inexperience in Environmental Monitoring for sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role. Show more Show less
FIND ON MAP
Pharmaceutical Manufacturing
5001-10000 Employees
278 Jobs
Key People
Company Reviews
View ReviewsMy Connections Amneal Pharmaceuticals
Download Chrome Extension (See your connection in the Amneal Pharmaceuticals )
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.