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
Amneal is looking for Regulatory Affairs-US Market professionals at Ahmedabad.
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.
- Active involvement in all the group activities and support to team member for routine work to accomplish the targeted submission.
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.
- Proof reading of soft copy, hard copy, transparency, shade cards and first print of all labeling components.
- To compile and review annual reportable change received from the agency in supplement approval letter and all Annual Reportable changes are submit in next Annual Report cycle.
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
- Routine tracking of all shipment against orders and updating to internal team
- Coordination with finance team for all pending payments against orders
- Keeping oneself updated with the various ICH guidelines and FDA requirements and presenting them internally on routine basis
If interested, please share CV at pujas@amnealindia.com
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