Analytical Scientist II

DIFGEN PHARMACEUTICALS PRIVATE LIMITED; Telangana; On-site; INR 700,000 - 1,000,000; Full time

Benefits offered by this job

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Job summary

DIFGEN PHARMACEUTICALS PRIVATE LIMITED in Hyderabad is seeking an experienced Documentation Specialist to support AR&D functions. You will create and manage project documentation, ensure change controls, and coordinate with QA and regulatory teams to keep the product pipeline moving.

A BS or MS in chemistry with 8+ years in a pharmaceutical lab is required; strong writing, organization, and cross-functional communication are essential; knowledge of GMP and analytical methods is expected.

Qualifications

• Bachelor’s degree in chemistry or related field.
• Master’s degree in chemistry or related field.
• Strong writing and documentation skills.
• GMP and safety practices knowledge.

Responsibilities

• Create and manage project documentation including change controls and reports.
• Coordinate with QA for change requests and document specifications.
• Assist with DMF/analytical documentation as needed.
• Support AR&D documentation requirements across departments.
• Track tasks and deliverables and ensure timely completion.

Skills

Organizational skills

Communication skills

Writing skills

GMP knowledge

MS Word

MS Excel

PowerPoint

Analytical chemistry

HPLC

GC

Titration

Education

B.S. in chemistry

M.S. degree

Tools

MS Word

Excel

PowerPoint

Job description

Job Details

Job Location: DifGen Pharmaceuticals Pvt Ltd- R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072

Salary Range: ₹700,000.00 - ₹1,000,000.00 Salary/year

Job Shift: Day

Job Summary

The incumbent will provide documentation support for various AR&D functions as determined by project assignments. The position will work closely with AR&D members and cross functional departments to coordinate and facilitate the various needs of the department. Accomplishments will be objectively determined by the successful and timely completion of coordintation and support activities, including documentation creation and implementation. The position exists to support the ongoing creation and execution of the product pipeline for the company.

Job Responsibilities

• Responsible for creating and managing project documentation, including change control documents, raw material specification, forms, protocols, reports, and other documents as assigned to support AR&D needs.
• Co-ordinate with QA for Change request for all project related activities.
• Co-ordinate with QA department to make specification/test methods effectiveness.
• Responsible for coordinating with the Purchasing Department as required for API related documents to support project needs.
• Responsible for assisting with the DMF review.
• Responsible for assisting in communication of general AR&D requirements to other departments.
• Responsible for supporting or assisting with the stability protocol preparation.
• Responsible to co-ordinate with regulatory department for any analytical documents requirements.
• Responsible for operating in accordance with the company’s Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Other related responsibilities as assigned by R&D management.

Major Duties

• Creation of specifications for raw materials and supplies for R&D projects, and collection of documents required to support raw material assessments
• Creation of method validation/verification/transfer Protocols/reports, analytical test procedure, summaries, and other related documentation.
• Review and assess DMF to support API related analytical documents for development projects
• Work with offsite groups to assist with the transfer of information to the Aveva site in support of R&D Projects
• Assist with the document review, preparation of project requirement, data compilation to support project requirements under supervisor guidance.
• Carry out change control process for any document preparation in trackwise system.
• Work with R&D leads to satisfy project requirements.

Qualifications

Job Requirements

Education

• Bachelor’s degree (B.S.) in chemistry or related field
• Master’s degree (M.S.)

Knowledge, Skills and Abilities

• Strong organizational and communication skills, ability to work effectively with internal and external team members and work effectively as a team member
• Ability to track project tasks and deliverables
• Strong writing skills and ability to write clear, concise, documents of a technical nature
• General knowledge of the pharmaceutical work environment, such as GMP and safety practices
• Computer skills including MS Word, Excel, Powerpoint, and other relevant software programs
• Analytical chemistry and common instrumentation
• General understanding of HPLC, GC, Drug Release, UV, IR, Titration.

Experience

• At least eight (8) years experience in pharmaceutical laboratory (B.S)
• At least five (5) to seven (7) years experience (M.S.)