Senior Associate - QA (Documentation & Support) (WFH)

About the job:Key responsibilities:

1. Prepare, organise and maintain SOPs, work instructions, process flows, templates, checklists and other controlled documents.

2. Document pharmacovigilance workflows, including AE identification, intake, recording, triage, escalation, follow-up and reporting.

3. Document product complaint processes, including identification, classification, escalation and tracking.

4. Support documentation of AI system requirements, functional specifications, risk assessments, test protocols, validation evidence, change controls and traceability matrices.

5. Document medical information workflows, including out-of-scope queries, complex escalations and human intervention.

6. Maintain records related to data handling, access controls, confidentiality, retention, audit trails and patient information protection.

7. Support inspection readiness through organised repositories, version histories, training records, review and approval records, and CAPA evidence.

8. Coordinate with development, QA, and business teams to identify documentation gaps and close assigned actions on time.Who can apply:Only those candidates can apply who:have minimum 1 years of experienceSalary:₹ 2,00,000 - 2,40,000 /yearExperience:1 year(s)Deadline:[hidden]:59:59Skills required:Report Writing, Pharmacovigilance, Document Management, Report Generation and Document ReviewOther Requirements:A. Eligibility:1. Candidates with a degree in pharmacy (B.Pharm/M.Pharm), life sciences, biotechnology, clinical research, or a related field, and at least two years of relevant professional experience.2. Strong verbal and written English, attention to detail, and an organised working style.3. Working knowledge of MS Word, Excel, PowerPoint, and document management.4. Ability to understand technical processes and convert them into clear, structured documentation.5. Willingness to learn pharmaceutical quality systems, pharmacovigilance, and regulatory documentation.6. Responsible approach to confidentiality, data integrity, and sensitive information.B. Preferred Skills:1. Basic knowledge of pharmacovigilance, AE reporting, product complaints, medical information, or pharmaceutical QA.2. Exposure to SOPs, GxP documentation, Good Pharmacovigilance Practices (GVP), computerised system validation, or software testing documentation.3. Interest in AI-enabled healthcare, software validation, risk management, and regulated technology.4. Practical experience in pharmaceutical quality, clinical research, regulatory affairs, or controlled documentation.5. Candidates with strong documentation skills, structured thinking, and a willingness to learn are encouraged to apply.About Company:MedRenova Pvt. Ltd. is a Pune-based pharmaceutical R&D startup working at the intersection of pharmaceutical innovation, AI and technology. MedRenova is focused on developing differentiated and innovative solutions for the pharmaceutical and healthcare industry, with a strong emphasis on addressing unmet needs.

Our team brings together extensive experience across pharma R&D, scientific research, AI/ML and technology. We work on innovative solutions that combine scientific expertise with emerging technologies to create meaningful opportunities in the pharmaceutical and healthcare space.

Responsibilities

Key responsibilities:

1. Prepare, organise and maintain SOPs, work instructions, process flows, templates, checklists and other controlled documents.

2. Document pharmacovigilance workflows, including AE identification, intake, recording, triage, escalation, follow-up and reporting.

3. Document product complaint processes, including identification, classification, escalation and tracking.

4. Support documentation of AI system requirements, functional specifications, risk assessments, test protocols, validation evidence, change controls and traceability matrices.

5. Document medical information workflows, including out-of-scope queries, complex escalations and human intervention.

6. Maintain records related to data handling, access controls, confidentiality, retention, audit trails and patient information protection.

7. Support inspection readiness through organised repositories, version histories, training records, review and approval records, and CAPA evidence.

8. Coordinate with development, QA, and business teams to identify documentation gaps and close assigned actions on time.