What are the responsibilities and job description for the Quality Associate I position at WhiteCrow Research?
About WhiteCrow
We are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in-house research.
About our client
Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.
By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.
As a Quality Associate I, you will be responsible for...
- Providing daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.
- Ensuring adherence to cGMP, SOPs, and regulatory standards.
- Leading and executing QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.
- Developing, implementing, and maintaining site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities
- Ensuring proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.
- Taking active role in preparing the site for regulatory inspection.
- Acting as a QA representative during regulatory inspections, internal audits, and customer audits.
- Contributing to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.
What you already have...
Qualifications/Experience
- Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).
- 5 years of experience in pharmaceutical manufacturing, or QA.
- Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.
- Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.
- Experience supporting regulatory inspections and validation documentation reviews.
Skills/Competencies
- Strong knowledge of 21 CFR part 10, and 211.
- Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.
- Excellent organizational and communication skills with high attention to detail.
- Ability to work collaboratively with operations, and engineering.
- Commitment to data integrity, continuous improvement, and patient safety.