Amneal Pharmaceuticals is hiring For Engineering / Regulatory Affairs / Strategic Sourcing (Procurement).Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.
Vacancy Details :
- Company Name: Amneal Pharmaceuticals
- Location : Ahmedabad
- Post Name: Engineering / Regulatory Affairs / Strategic Sourcing (Procurement)
- Qualification: B.pharm, M.Pharm,Diploma / B. E
- Experience: 2 to 8 Years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: 2,00,000 – 7,00,000 P.A.
- Contact: kavitriy@amnealindia.com,pujas@amnealindia.com
- Mode of application : OnlineÂ
- Selection Process: interview
Job Description/Skills Required :
Multiple Openings in Engineering at Amneal Biologics, Bavla Plant
We are having multiple positions in Engineering team for our newly setup Biologics Plant at Bavla, Ahmedabad
Designation: Executive/Senior Executive – Utility
Experience Required: 3-5 Years
Qualification: B. E. – Mechanical
Job Responsibilities:
- To Operate, maintain utility and plant maintenance, To do the various project
- To handle utility and plant maintenance
- Operation & Maintenance of PSG & distribution system on daily basis
- Operation & Maintenance of MCDP system
- Operation & Maintenance of WFI storage & distribution system
- Operation & Maintenance of PW storage & distribution system
- Schedule activities of Water system to be performed
- Handling, Operation & Maintenance of utility
- Sanitization, Passivation, cleaning, disinfection activities to be performed.
- To handle the preventive maintenance of plant equipment
- Preventive & breakdown maintenance to be performed.
- Documentation to be done as per cGMP.
- Maintain the required chemical stock and inventory.
- Follow the GDP.
- Do the green field and various projects.
Designation: Executive/Senior Executive – Electrical
Experience Required: 5-7 Years
Qualification: Diploma / B. E. – Electrical
Job Responsibilities:
- Operation and maintenance of utility equipments and electrical system
- 100 % uptime of all equipment
- Maximum utilization of capacity.
- Responsible to operate the PCC and utility equipments efficiently.
- Responsible to maintain the critical spares inventory for utility equipment.
- Responsible to provide necessary utility to production department or other user
- Responsible to update and maintain all PCC and utility equipment records per SOP.
- Responsible to carry out all work as per cGMP and GEP.
- Responsible to carry out preventive maintenance as pe SOP.
- Responsible to attain any breakdown within short time and in line with handling breakdown Responsible to maintain the utility equipment quality parameter within range as per SOP.
- Responsible to keep the PCC and utility area and equipment neat and clean.
Designation: Senior Executive / Asst. Manager – Water System
Experience Required: 5+ Years
Qualification: B. E. – Mechanical
Job Responsibilities:
- Handled Water system Independently and Guide Down the Line Team for the same
- Handling, Operation & Maintenance of utility ( Water System )
- Sanitization, Passivation, cleaning, disinfection activities to be performed.
- To handle the preventive maintenance of water system
- Preventive & breakdown maintenance to be performed.
- Documentation to be done as per cGMP. And USFDA
- norms
- Maintain the required chemical stock and inventory.
- Follow the GDP.
- Do the green field and various projects.
Designation: Senior Executive / Asst. Manager – Civil
Experience Required: 3-6 Years
Qualification: B. E. – Civil
Job Responsibilities:
- Civil and PEB Structure for Green Field project
- 100 % uptime of Civil & PEB
- Work in time
- Responsible to handle the Green Filed Civil Work Land Filling to PEB Structure with coordination with Structure Eng.
- Responsible to perform the preventive maintenance activity of Civil and PEB PM schedule and as per respective SOP.
- Responsible to assist engineer in Execution and Maintenance of Civil Structure .
- Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance.
- Responsible to intimate the shift engineer immediately for critical breakdown.
- Responsible to report the shift engineer for daily breakdown and its corrective action. Other duties as assigned
Designation: Asst. Manager – QMS/HVAC/Documentation
Experience Required: 8-10 Years
Qualification: B. E. – Instrument Engg.
Job Responsibilities:
- QMS / Documentation / HVAC
- 100 % uptime of all equipment
- Maximum utilization of capacity.
- Responsible to handle QMS and documentation of Engineering department
- Responsible to qualification activities of HVAC, Water system and Mfg.
- Responsible to assist engineer in Execution of Quality system DQ/IQ/OQ/PQ
- Responsible to generate tools and parts requirement for daily breakdown and Preventive maintenance.
- Responsible to intimate the shift engineer immediately for critical breakdown.
- Responsible to report the shift engineer for daily breakdown and its corrective action. Other duties as assigned
If interested, please share CV at pujas@amnealindia.com
Multiple Opening in Regulatory Affairs (Only US Market): Amneal Pharma
Department: Regulatory Affairs (Injectable/Sterile)-US Market
Designation: Executive/Senior Executive and Manager
Function: Regulatory Affairs-Pre Approval
Experience Required: 3-12 Years
Job Responsibilities:
- Experience of ANDA and FDA query response submission for Injectable, Ophthalmic, Otic, and Complex Injectable Products.
- Review of documents with respect to compliance to regulatory guidelines and submission requirements for Injectable, Ophthalmic, Otic, and Complex Injectable Products within timeline.
- Review of technical documents received from R&D, ARD, QA, QC, Production and CROs for ANDA submissions.
- Preparation and submission of quality dossier as per regulatory requirements within timeline.
- Primary review of API DMFs and follow up with concerned team to get all required documentation.
- Basic literature search and preparation of White Papers for Ophthalmic and Otic Products projects.
- Preparation of cover letter and sections for Amendments and Critical Supplements.
- Co-ordination with R&D, ARD, QC, QA, Clinical, Labeling team for completion of assigned technical and regulatory task.
- Review of labeling for all assigned projects.
Department: Regulatory Affairs (OSD)-US Market
Designation: Manager
Function: Regulatory Affairs-Post Approval
Experience Required: 9-12 Years
Job Responsibilities:
- Extensive knowledge of ANDA submission activities and post approval
- procedures.
- API DMF review with respect to USFDA regulatory requirement.
- Thorough knowledge of solid oral dosage form and manufacturing process
- Ability to assess the change cases with respect to post approval USFDA
- guidance Knowledge of Post approval submission guideline and procedure for
- Annual report/CBE 0/CBE 30 and PAS filling
- Compilation of the Annual Report and ensuring its submission as per stipulated
- timeline.
- Ensure the no delay in submission always keen to adopt first to file approach.
- Ensure better management of major supplements submissions.
- High quality review of entire submission package to avoid any major
- deficiencies.
- Maintain regulatory information as per current department practice.
- Coordination with Cross Functional teams for the documents availability.
Department: Regulatory Affairs (e-CTD Publishing)-US Market
Designation: Officer/Executive
Function: e-CTD Publishing
Experience Required: 2-5 Years
Job Responsibilities:
- CTD/e-CTD compilation, publishing, validation for US and EU Submissions.
- QC Check of PDF Files as per internal Regulatory Operations MaPP.
- Update the eCTD tracking sheet after uploading the documents.
- Archival and life cycle management of the e-CTD submission.
- Priority Management. Understand criticality of any given tasks and discuss any identified issues with RO Group Lead.
- Submission level publishing of PDF file like Uploading to eCTDXpress,
- External linking, Compilation, Validation and Submission to ESG Gateway.
- PDF Document check as per PDF specification required for US FDA requirements.
- Quality work for all assigned publishing and review task by Group lead.
- Well aware about the possible FDA eCTD related deficiency and focusing on preventing them with goal of no eCTD deficiency in every submission project.
- Co-ordinate with RA CMC project manager for submission data and their timely submission to Agency.
Department: Regulatory Affairs (Labelling)-US Market
Designation: Executive/Senior Executive
Function: Labelling
Experience Required: 2-5 Years
Job Responsibilities:
- Labeling part of Original ANDAs and Amendments (DRL/IR/CR).
- Labeling Supplements: To prepare and review below labeling components and RLD word documents; Amneal Redline; and Labeling SBS (side-by-side) of Package insert and carton/container labeling.
- Revise Structure Product Labeling (SPL) to ensure FPL (Final Printed Label) is available for submission.
- To ensure current version of Container/Carton/Blister label is available for Ok-to-print activity.
- To ensure that labeling modules are available for submission.
- Preparation and review of labeling component of site transfer projects [i.e. word file, Redline, Clean file, Structured Product Labeling (SPL)].
- To ensure availability of all artwork (FPL, container, carton and blister label) and review the same.
- Initiate change controls as and when required for labeling changes.
- To prepare and review Cover Letter and 365h form for all supplements.
If interested, please share CV at kavitriy@amnealindia.com
Opening in Strategic Sourcing (Procurement) @ Corporate Office – Amneal
We are looking for a person for our Technical Team-Strategic Sourcing & Supply Management at corporate office Ahmedabad.
- Department: Strategic Sourcing & Supply Management -US Market
- Designation: Executive/Senior Executive / AM / Manager
- Experience Required: 2-9 Years
- Qualification: B. Pharm/M. Pharm
Note: Candidates working in QA / RA / Analytical R&D department at plant and are willing to work for Strategic Sourcing team at corporate office can apply.
Job Responsibilities:
- Support supervisor for End-to-end coordination for all projects, interacting with the API vendors and internal teams (Analytical, formulation, Regulatory, QA/QC) to resolve all technical concerns (Documents/analytical issues/material quality) and fulfil requirements for ANDA submission and Regulatory Agency deficiencies.
- Close coordination with Packaging material and Excipient vendors, arranging technical documents to Analytical and Regulatory teams satisfaction, resolving ARD/QCs technical issues by discussion with Raw material vendors
- Coordination with the QA/RA and commercial team for approvals of all Labelling components (Package inserts/outserts, Medications guides, labels, shade cards)
- Coordination with the QA team and material vendors for all complaints on raw material quality
- Coordination with API/Excipient/Packaging suppliers for Quality Agreements, VAQs and other QA requirements
- Preparation and maintenance of database and/or spread sheets for all Projects and their technical parameters to ensure all key information is available for reference, information and decision making
- Understanding the impact of changes in Raw material process/specifications and preparation of Change controls and coordinating with internal teams for timely closure
- Preparation of Purchase orders and coordination with logistics team for any in-warding concerns
If interested, please share CV at pujas@amnealindia.com
