Hybrid Analytical Technical Writer at Clinchoice

Job Title: Analytical Technical Writer

Employment Type: Full-time

Location: Mumbai Experience: 2-4 years

Job Description: 

• Preparation & review of analytical technical documents from the laboratory data such as and but not limited to, Product specifications, analytical test methods, analytical method validation protocol, method validation reports, analytical method transfer protocol, method transfer reports, stability study protocol and stability study report etc.

• Coordinate with client stakeholders and external laboratories to collate required documentation.

• Change control management from initiation to approval in coordination with cross function teams and drive to implement the changes timely. 

• Ability to read the analytical laboratory data and summarize the contents into report format.

• Experience to ensure completeness and accuracy of the technical reports.

• Experience in managing the lifecycle of technical reports/documents.

• Supporting cross functional team in sharing the technical documents for submission requirements.

• Follow client documentation standards and best practices.

Qualifications and desired skills: 

• Minimum M. Sc. Chemistry, M. Pharmacy, or related scientific field.

• 2-4 years of working experience in Quality Control/QA documentation/R&D or/and Analytical Quality Assurance, with strong analytical thinking.