Engineer-II - 3-5Yrs

Rangam Infotech Pvt. Ltd.; Bengaluru; On-site; INR 6,00,000 - 10,00,000; Full time

Job summary

A pharmaceutical company in Bengaluru is seeking a documentation specialist to manage quality agreements, support R&D documentation, and assist with quality assurance. The ideal candidate has a Master's in science or similar, along with 3-5 years in quality control or regulatory functions in the pharmaceutical industry. Strong communication and organizational skills are essential for this role.

Qualifications

• 3-5 years of quality, regulatory experience in drugs/pharmaceutical and medical devices.
• Experience in Quality Control lab and testing of raw materials.
• Experience in creating product data sheets and specifications.

Responsibilities

• Maintain updated quality agreements and alert as needed.
• Manage periodic review of documents and procedures.
• Assist in training on documentation processes.
• Coordinate with R&D on documentation-related issues.
• Support quality activities during audits.

Skills

Organizational skills

Effective communication

Analytical skills

Fluency in English

Document processing knowledge

Microsoft Office proficiency

Training skills

Customer responsiveness

Education

Master’s in science/M. Pharm./B. Tech

Tools

MS Word

MS Excel

MS PowerPoint

SharePoint

Job description

• Maintains an updated list of quality agreements and alerts whenever required
• Ensures integrity of information and data in documents.
• Manages periodic review of documents, procedures and their impact assessment.
• Assistance in providing training on documentation related processes and systems.
• Communicating problems and suggesting workable solutions related to documentation.
• Create and edit documents following guidelines as outlined in the division documentation SOPs (Standard Operating Procedures), GDP (Good Documentation Practices), and configuration manual.
• Supports in preparing, processing and delivering Quality and R&D documentation to R&D department.
• Create, Issue and control documents associated with R&I specification with minimal supervision.
• Assist in providing training on documentation processes and systems.
• Ensure appropriate documentation is complete, correct and that quality schedules are met.
• Coordinate and support R&D employees in documentation related issues.
• Understanding all required steps in the documentation process, identifying more efficient process(s) and updating the corresponding procedure(s) accordingly.
• Supports quality activities during internal/external audit and other quality projects as needed.
• Manages issuance and effectiveness of documents in TcU application.
• Provides support on the preparation of the Site-Quality review as necessary.
• Project management which includes managing change controls –using client'sin-house quality systems like TW8 and TcU.

Qualifications:

• Demonstrate good organizational skills and prioritize multiple projects and tasks efficiently.
• Must demonstrate effective communication skills, must be able to negotiate and resolve conflicts in an amicable manner for win-win situations for the impacted parties.
• Good analytical skills to notice error(s) in documentation and to take appropriate corrective actions.
• Fluency in English (both written and oral).
• In-depth knowledge of document processing and data management.
• Good command over Microsoft office tools (MS Word, MS Excel, MS PowerPoint, or SharePoint).
• Have skills in effectively training R&D employees and supporting their activities.
• Demonstrate responsiveness to customer needs within job scope.

Education and/or Experience:

Master’s in science/M. Pharm. /B. Tech with 3-5 years of quality, regulatory or combination of both in drugs/pharmaceutical and medical devices space. Must have worked in Quality Control lab and experience on testing of incoming raw materials and release of finished goods. Must have experience in creating product data sheets, incoming specifications and product specification documents.