Associate (Quality Assurance – Operations/ Compliance/ Investigations)

Responsible for execution and review support of Quality Assurance (Operations/ Compliance/ Investigations) activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.

Responsibilities

Responsible for execution and review support of Quality Assurance (Operations/ Compliance/ Investigations) activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements; Review QC documents (BQ, CQ), batch records, and related documents; Support shop-floor QA activities including GMP compliance monitoring and process checks; Perform in-process checks and support batch documentation review; Review SOPs, specifications, STPs, and study protocols; Support audit activities, inspection readiness, and regulatory commitments; Ensure adherence to cGMP, GDP, and regulatory requirements; Support quality systems such as Change Control, CAPA tracking, and document management; Assist in data integrity and documentation control activities; Support deviation investigations and CAPA implementation; Assist in root cause analysis using investigation tools; Track investigation closure within timelines; Ensure proper documentation of investigation records

Requirements

B. Pharm/M. Pharm/M.Sc.; Master’s Degree: 2–3 years; Bachelor’s Degree: 4–5 years; Experience in Pharma / Biotech QA, QC, or Manufacturing; Change Management process experience; Risk assessments principles and tools; Validation of manufacturing equipment’s; Drug Product Process validations; Regulatory requirements; Compendial Changes; Knowledge on Regulatory Guidelines, Good documentation practices and Good Manufacturing Practices; Thorough understanding of 21CFR 211, Pfizer Quality Standards, site procedures and Processes; Strong Interpersonal skills; Ability to communicate effectively with all levels within the organization; Compliance driven approach, knowledge on cGMP and regulations; Should face national and international inspections such as USFDA, MHRA, TGA & WHO; Fundamental knowledge of manufacturing and quality control processes (solution preparation, filling, sterilization, visual inspection, packaging); Document review and Good Documentation Practices; Basic knowledge of change control and risk assessment; Knowledge of chemical and microbiology testing; Interpersonal Skills: Effective communication with all staff from different levels; builds constructive and effective relationships; Acts Decisively: Makes decisions in a timely manner based on available information; Grows Self: Identifies individual development needs and works towards achieving those objectives; Critical thinking and compliance mindset; Ability to work in cross-functional teams