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Qa Controlled Docs Sr. Coordinator

Fortrea
Fortrea
4-6 years
Not Disclosed
Bangalore, Mumbai, India
10 April 6, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Coordinator – QA Controlled Documents | Full-Time | Bangalore / Mumbai, India
Experience Required: 4–6 years

Job Description:
We are seeking a detail-oriented Senior Coordinator – QA Controlled Documents to support Quality Assurance (QA) and Regulatory Compliance (RC) functions in managing controlled documentation within a regulated environment. This role is critical in ensuring the accuracy, accessibility, and compliance of controlled documents in alignment with GxP standards and Quality Management Systems (QMS).

The ideal candidate will have strong experience in document control processes, regulatory compliance, and quality systems within pharmaceutical, biotechnology, or CRO environments.

Key Responsibilities:

Document Control & Management

  • Administer and manage controlled documents, ensuring accurate version control, timely distribution, and accessibility for end users.

  • Maintain document lifecycle processes in compliance with SOPs, Work Instructions, and regulatory requirements.

  • Perform quality checks on documentation to ensure accuracy, completeness, and compliance.

Quality Assurance & Compliance

  • Ensure adherence to Quality Management Systems (QMS), GxP standards, and regulatory guidelines.

  • Support CAPA (Corrective and Preventive Actions) processes and maintain associated documentation.

  • Assist in audit readiness and participate in internal and external audits as required.

  • Ensure all QA and regulatory compliance responsibilities are executed in line with controlled documentation.

Process Improvement & Reporting

  • Track, monitor, and report document control metrics as defined by management.

  • Support the implementation of new or revised processes, procedures, and quality initiatives.

  • Identify process improvement opportunities and contribute to continuous quality enhancement.

Issue Management & Collaboration

  • Ensure timely escalation and resolution of issues impacting document release and compliance.

  • Collaborate with cross-functional teams to ensure efficient document workflows and regulatory alignment.

  • Communicate effectively with stakeholders to support quality and compliance objectives.

Training & Administration

  • Complete all required training programs within defined timelines.

  • Support training initiatives related to document management systems and QA processes.

  • Perform administrative and operational tasks as required by the QA function.

Qualifications & Experience:

  • Bachelor’s degree in Life Sciences or related field (or equivalent experience).

  • 4–6 years of experience in a regulatory or GxP-compliant environment.

  • Strong knowledge of Quality Management Systems (QMS) and CAPA processes.

  • Hands-on experience with document management systems such as Veeva Vault.

  • Experience with audit processes and regulatory inspections is an advantage.

  • Strong analytical, organizational, and problem-solving skills.

  • Excellent communication and interpersonal skills.

  • Ability to manage multiple priorities while maintaining high-quality standards.

Location: Bangalore / Mumbai, India (On-site role)

Why Join Us:

  • Work in a quality-driven environment supporting global regulatory compliance initiatives.

  • Gain exposure to advanced document management systems and QA processes.

  • Collaborate with cross-functional teams in a structured and compliance-focused setting.

  • Access opportunities for professional growth and development in quality assurance.