ScieGen Pharmaceuticals India Pvt. Ltd. has announced an exciting career opportunity for experienced pharmaceutical professionals in the Analytical Development Department. The company is hiring for the position of Documentation Officer / Specialist at its Jadcherla, Telangana facility. This role is ideal for candidates with strong expertise in analytical documentation, method development records, validation reports, and regulatory compliance.

Professionals with 2–3 years of experience in pharmaceutical analytical development and documentation can leverage this opportunity to advance their careers in a quality-driven and compliance-focused environment.

Job Overview

Details

Company

ScieGen Pharmaceuticals India Pvt. Ltd.

Department

Analytical Development

Position

Documentation Officer / Specialist

Experience

2–3 Years

Qualification

B.Pharm / M.Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences)

Location

Jadcherla, Telangana

Industry

Pharmaceutical Research & Development

Key Responsibilities

The selected candidate will be responsible for maintaining high-quality analytical documentation and ensuring regulatory compliance across development activities.

Major Duties Include:

Preparation, review, and maintenance of analytical development documents.

Documentation of analytical method development and validation activities.

Preparation and review of protocols, reports, specifications, and STPs.

Ensuring compliance with GMP, GLP, and applicable regulatory guidelines.

Coordination with cross-functional departments to support documentation requirements.

Maintaining accurate records and ensuring data integrity standards are followed.

Required Qualifications

Candidates applying for this role should possess:

B.Pharm, M.Pharm, or M.Sc. in Chemistry/Pharmaceutical Sciences.

2–3 years of relevant experience in pharmaceutical analytical development documentation.

Strong understanding of GMP and GLP requirements.

Knowledge of analytical method validation and regulatory documentation.

Good communication and technical writing skills.

Why Join ScieGen Pharmaceuticals?

ScieGen Pharmaceuticals offers a professional environment focused on innovation, quality, and regulatory excellence. Employees gain exposure to advanced pharmaceutical development processes while working alongside experienced scientific and quality teams.

Benefits of the Role

Exposure to analytical development projects.

Opportunity to strengthen regulatory documentation expertise.

Career growth in pharmaceutical R&D and quality systems.

Collaborative and compliance-focused work culture.

Application Process

Interested candidates can submit their updated resume and portfolio to:

Email: bhaskara@sciegenpharm.com

Website: www.sciegenpharm.com

Applicants are advised to highlight their experience in analytical documentation, method validation, and regulatory compliance while applying.

Technical FAQs

1. What is the role of documentation in analytical method development?

Documentation ensures that all analytical activities are traceable, reproducible, and compliant with regulatory requirements. It includes method development records, validation reports, protocols, and change controls.

2. What is an STP in pharmaceutical analytical laboratories?

STP stands for Standard Testing Procedure. It provides detailed instructions for performing analytical tests consistently and accurately while maintaining regulatory compliance.

3. What are the key parameters evaluated during analytical method validation?

Typical validation parameters include:

Accuracy

Precision

Specificity

Linearity

Range

Robustness

Detection Limit (LOD)

Quantitation Limit (LOQ)

4. Why is GMP compliance important in analytical documentation?

Good Manufacturing Practice (GMP) compliance ensures that documentation accurately reflects laboratory activities, supports product quality, and satisfies regulatory inspection requirements.

5. How does data integrity impact analytical documentation?

Data integrity ensures that laboratory records are complete, accurate, consistent, and attributable throughout the data lifecycle. Regulatory agencies expect compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more).