Latest MPharma Jobs at Amneal l Apply Now for Executive – QC Tech Writer Role.
Amneal is actively seeking a skilled Executive – QC Tech Writer to join its team in Ahmedabad, Gujarat. This exciting opportunity is ideal for professionals with expertise in analytical method validation, CTD documentation, and stability profiling. If you’re passionate about scientific writing and ensuring pharmaceutical quality compliance, this role offers the chance to make a significant impact in the healthcare sector.
Executive – QC Tech Writer
Location: Ahmedabad City, Gujarat, India
Status: Hot Job
Job Description:
- Creation/Revision/Review of Specifications and Methods for Site Transfers and ANDAs
- Method Validation Protocol knowledge
- Creation/Revision/Review of Validation Report for Drug substance, Excipients, and Drug products
- Initiate Change controls as necessary for Method and specification revisions and stability Protocol.
- Module 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 a vendor qualification report based on the performance of the material at the test
- To prepare justification reports towards the reduction of tests in Input material testing, such as raw and packaging material, In-process testing, Finished product testing, and 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 the Team
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.
Key Roles of the Human Resources Team
- Executive Role: Specialists in all aspects of people management. High-level input at a 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 its managers on any aspect of workforce management and employee relations, and performance.
- Service Role: Ensure the organization is fully aware of and equipped to deal with developments impacting employment matters, such as changes in legislation and shifts in the labor market’s characteristics.
Keywords: Executive, QC Tech Writer, Latest MPharma Jobs, Job Posting, Ahmedabad, Gujarat, India, Method Validation, Laboratory Instrumentation, Data Integrity, Impurity Profiling, Stability Profiling
