Multiple Openings for Experienced in Procurement / R&D / Packaging Development / Project Management / Regulatory Affairs Departments @ Amneal Pharmaceuticals Ltd - PHARMA WISDOM

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Saturday, 26 September 2020

Multiple Openings for Experienced in Procurement / R&D / Packaging Development / Project Management / Regulatory Affairs Departments @ Amneal Pharmaceuticals Ltd

 

Dear Candidate,

Greetings!

Openings - Procurement Department @ Amneal Ahmedabad

We have multiple requirements in Procurement Department at Corporate Office, Ahmedabad.

Position: Manager / Sr. Manager

Exp: 7-12 yrs

Primary Functions:

  • Configuration of Enterprise Structure for MM; like Plants, Purchasing Organization, Storage locations etc •
  • Knowledge of MM Master data viz. Material master, Vendor master & Purchase information record •
  • Knowledge of creation of material master, customer master, Vendor master, Source List, purchase info record, Sales representation, Profit Center, GL account, Cost center in SAP.
  • Knowledge of Purchasing Documents viz. Purchase Requisition, RFQ, Purchase Order, Contracts
  • Knowledge of Sales Documents viz , Quotation & Sales Order.
  • Special Procurement Types viz. Consignment, Subcontracting, Pipeline, Third Party Processing, Stock transport Oder.
  • Knowledge of SAP Access & security module i.e. giving access, assigning roles & resting SAP password
  • Ability to create SAP master & transaction data script by using Winshuttle Transaction & Studio 11.3 ,11.2.12 version for mass upload & data migration purpose.
  • Vendor Master Data creations, amendments and maintenance/deletion of vendors (Suppliers)
  • Supports functional/business leaders with vendor master reports
  • Creates/maintains/Documents queries and reporting
  • Maintains and updates the weekly Vendor Master data dashboard
  • Knowledge of Document creation in SAP
  • Ensure proper validations & duplicate checks are done before setting up of a vendor in global master data.
  • Extension of vendor codes to company codes and purchase organizations as requested.
  • General data detail changes of vendor
  • Financial sensitive fields updating in regional fields
  • Vendor banking details updating.
  • Key Player in Vendor master management (Creation and Modification).
  • Mass maintenances in masters for any changes in business.
  • Mailbox handling from AP team to change vendor master

Please share your CV at pujas@amnealindia.com along with Current & Expected CTC.

Multiple Requirements - R&D- INJ_ PD @ Amneal Ahmedabad

We have multiple requirements in R&D -Injectable in Product Development at Ahmedabad for Injectable dosage form.

Position: Manager / Sr. Manager AGM / DGM

Exp: 7-12 yrs

Primary Functions:

  • Candidate Should have exposure of Injectable products only
  • R&D Product Develpment experience is must.
  • Should have expertise into Injectables / Complex Injectables & Opthalmic.
  • Please do not apply in case if you have OSD / API Exposure.
  • US / EU market exposure is must.

Please share your CV at pujas@amnealindia.com along with Current & Expected CTC.

Opening - R&D Packaging Development - AGM/DGM/GM @ Amneal Ahmedabad

We have requirements in R&D Packaging Development at Ahmedabad for Injectable dosage form.

Position: AGM / DGM / GM

Exp: 10-20 yrs

Primary Functions:

  • Candidate Should have exposure of Injectable products only
  • R&D Packaging Develpment experience is must.
  • Should have expertise into RLD Pack Reverse Enggineering & Drug device combinations for Injectables / Complex Injectables & Opthalmic.
  • Please do not apply in case if you have MNF-Packaging Development Exposure.
  • US / EU market exposure is must.

Please share your CV at pujas@amnealindia.com along with Current & Expected CTC.

Urgent Requirement - Project Management Department

We have multiple requirements in Project Management at our R&D centre Ahmedabad for Injectable & OSD dosage form.

Position: Sr. Exe to AGM

Exp: 8-13 yrs

Job Responsibilities:

  • This position will build an accomplished PM program by developing and designing efficient and innovative systems to provide unique solutions and support to the various functional heads and executive management.
  • Must possess skills to be a strong people manager with ability to develop and groom internal talent and have a solid understanding of the various aspects of the generic business.
  • Lead and manage all activities related to product development through the entire product cycle from strategic and tactical perspectives and with internal and external stakeholders. Be a thought leader to anticipate issues and propose creative solution on a functional basis.
  • Continue to proactively build new PM systems to meet evolving business needs.
  • Possess a deep understanding of the technical details underlying product development to effectively strategize, plan and co-ordinate project activities with the functional stakeholders and senior management.
  • Ability to lay specific emphasis on complex programs and projects across dosage forms and significantly contribute to the technical and other strategic perspectives as part of decision making.
  • Lead PM as an independent function to effectively manage budgets, communicate project expectations and timelines, proactively anticipate project related issues and devise contingency plans.
  • Build strong relationships with cross-functional and multi-disciplinary stakeholders to drive various project requirements in an efficient manner.
  • Must have the capability to build strong team dynamics of diverse individuals representing the various functions as part of product development.
  • Must have the ability to work with external vendors such as CROs, CMOs, consultants, material vendors and other external third parties to drive a strong development program for the US markets.

Requirements

  • Must be a high energy, assertive and detail oriented individual with a strong technical background and deep understanding of product development.
  • A well-developed understanding of the generic pharmaceutical development process acquired through a minimum of 5 years of industry experience in preferably one of the following areas: drug formulation / analytical development, clinical strategy development or project management.
  • Prior experience in Product development is an absolute requirement for this position. Understanding of multiple functional areas and exposure to complex dosage form development is required.
  • A thorough understanding of the Regulatory process and Intellectual Property issues as it pertains to ANDA filings is necessary.
  • A proven ability to manage teams and possess strong interpersonal, oral and written communication skills.

Please share your CV at pujas@amnealindia.com along with Current & Expected CTC.

Urgent Requirement - Manager / Sr. Manager in RA for Inhalation Dosage

We have requirements in Regulatory Affairs - MDI/DPI resource at Corporate Office Ahmedabad for Inhalation dosage form.

Position: Manager / Sr. Manager

Exp: 8-13 yrs

Primary Functions:

  • Compile, prepare, critically review and submit the US ANDAs and EU applications for Inhalation dosage form with high-quality, following the regulatory guidelines and internal processes within time lines.
  • Ensure timely submission of all assigned projects.
  • Ensure final US ANDA and EU applications meets the requirement of latest ANDA checklist recommended by USFDA and EU authorities to avoid any acceptance to file issue.
  • Prepare regulatory strategies for all assigned projects covering all key points.
  • Work very closely with US regulatory Project manager at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
  • Submit controlled correspondence to FDA on specific issues as needed for assigned projects.
  • Proactively raises major project issues to superior for resolution and agreement.
  • Evaluate final compositions for IIG and Proportionality similar criterias and develop regulatory strategies to avoid acceptable for filing issues.
  • Review the DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.
  • Proofread and approve labeling for assigned products.
  • Ensure that labeling complies with all federal, state and local requirements/regulations and component format conforms to specifications to assure optimal functionality.
  • Coordinates with external vendors for project support activities.
  • Track the committed timeliness and follow up with the internal departments proactively for required documents.

Secondary Functions:

  • Communicate with consultants, attorneys and external parties as needed to obtain scientific data for submissions.
  • Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
  • Maintain current knowledge of regulations and other issues that affect products and industry

Please share your CV at pujas@amnealindia.com along with Current & Expected CTC.

Regards,

Puja Sinha

Amneal Pharma


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