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Amneal Pharmaceuticals
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Executive - QC Tech Writer

Executive - QC Tech Writer

Amneal Pharmaceuticals

0 years

0 Lacs

Ahmedabad Gujarat India

Posted:2 months ago| Platform:

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Skills Required

qc controls stability analysis reports qos report testing packaging documentation instrumentation data integrity profiling diversity management support learning development

Work Mode

On-site

Job Type

Full Time

Job Description

Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs
Method Validation Protocol knowledge.
Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products.
Initiate Change controls as necessary for:

Method and specification revisions and stability Protocol

Modules preparation for Drug substance and Drug product.

Batch Analysis – 32S/32P
Reference Standards – 32S/32P
Characterization of Impurities – 32S/32P
Justification of Specification – 32S/32P
Facility Templates
Stability Summary Reports for ACC, CRT & RT
5313 Reports (Dissolution Comparative test)
QOS & Stability Overview - 32S/32P (If ANDA)

To prepare vendor qualification report based on the performance of material at test.
To prepare justification reports towards reduction of tests in Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing.
Preparation/Review of SOPs

Required Skills

Analytical method Validation documentation : Advanced
Laboratory Instrumentation Knowledge : Intermediate
Data Integrity (ALCOA+ principles) : Advanced
CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) : Advanced
Impurity Profiling & Justification : Intermediate
Stability Profiling Knowledge : Advanced

Qualifications

M. Pharmacy, M. Sc.

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.

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Executive - QC Tech Writer