QA Associate

Job Tittle : QA Associate

Essential Job Duties and Responsibilities

Employee is responsible for performing activities in compliance with current established

site procedures of safety and quality. Main and additional duties are mentioned below:

❖ Objectives and Responsibilities

➢ As a Quality Assurance personnel, ensure that the quality systems and processes

followed at Site meet the Global quality policy, GLOBAL standards, local procedures, and

current applicable cGMP guidelines.

➢ Compliance to applicable GLOBAL policies, GLOBAL standards, Local procedures, and

applicable regulations for each customer as determined by internal and external audit

results.

➢ Department Co-Ordinator for Record Management Process.

➢ Ensuring gap assessment for compendial changes are completed and deployed at site.

➢ Ensuring Quality records are handled adequately and in a compliant way before closing

out.

❖ Main Duties/Additional Duties/Sphere of authority

❖ Personnel

➢ Responsible for maintaining harmonious relationship with Managers and staff of

different departments and with the team members.

❖ Document Management

➢ Responsible for document management of QA procedures and other cGMP documents

as per the role assigned in electronic data management system.

❖ Data Integrity

➢ To Implement the data integrity requirements on Site

❖ Record Management

➢ Department Co-Ordinator for Record Management Process.

❖ Internal Auditing and Check Round Program

➢ Responsible for participating check rounds

➢ Responsible for participating in Internal Auditing program.

❖ Handling of Nonconformance/s

➢ Responsible for handling nonconformance(s) as per responsibilities specified in relevant

standard operating procedures.

➢ Approval of quality records and its final disposition after thorough impact assessments.

➢ Responsible for keeping oversight on adequate handling and timely closure of

nonconformance(s).

❖ Corrective action / Preventive action

➢ Responsible for reviewing the implementation of corrective and preventive actions as

per applicable standard operating procedures to meet cGMP requirements.

➢ Follow-up with CPA owners for closure of CPA’s

❖ Lab Support

➢ Responsible for approval of SOP’s, Protocols, Validation plans pertaining to

Qualification/Requalification, Calibration & Preventative Maintenance of lab equipment

of lab Equipment (such as LC, dissolution testers, UV, XRD, etc,).

❖ Training

➢ To act as Training Process Owner and Subject Matter Expert (SME) for Training Process

and ensure that the process is always followed and reviewed periodically.

➢ To collaborate with functional management (or their designee) in the identification of

training needs, development, and maintenance of training curricula for the Quality

Assurance laboratory and responsible for following key activities:

➢ Coordination of onboarding activities for new employees.

➢ Coordination and management of trainings for qualification of various roles in Quality

Assurance department as per need.

➢ To collaborate with the curriculum owners on training audience identification.

➢ To collaborate with content owners to evaluate the effectiveness of training, as needed.

➢ Responsible for maintaining training related documentation (training curricula and job

description) for all personnel in Quality Assurance as per current requirements.

➢ To complete trainings assigned in SUMMIT in timely manner

➢ To provide training to personnel at APDC site on Quality System SOP’s, cGMP topics &

provide cGMP advice.

❖ Quality & Compliance Support

➢ Responsible for ensuring that the quality systems followed in departments meet the

cGMP requirements, Global Quality Framework and standards, local procedures, and

applicable regulations.

➢ Responsible for data collection for management review meetings.

➢ Responsible for participating in regulatory assessment and Compendial assessment

program.

➢ Responsible for oversight for periodic review tracking of procedures.

➢ Responsible for participating in GMP Service Provider Process.

➢ Responsible for ensuring oversight on Pest Control Program.

➢ Responsible for quality oversight

❖ Compendia Changes and Regulatory Outreach

➢ Perform gap assessment for the existing Quality Systems with respect to new or updated

regulations and define and/or follow-up for the implementation of actions.

➢ Responsible for ensuring gap assessment for compendial changes are completed and

deployed at site.

❖ Regulatory Inspections

➢ Responsible for participating in Inspection Management Activity

➢ To participate in regulatory inspection readiness program.

❖ Minimum Qualification for the position:

➢ Graduate in Science discipline with thorough knowledge of GMP Regulations with

minimum experience of 3-4 years in Quality Role.

➢ Excellent/adequate verbal and written communication skills.

➢ Excellent/adequate computer proficiency.

➢ Excellent/adequate analytical skill to identify gaps and root causes of issues and think

out of the box to develop a solution.

➢ Must be able to work independently with minimum supervision to meet tight deadlines

and maintain a positive attitude.