Quality Control - Associate / Sr Associate

OneSource Specialty is looking for resources in Quality Control team. Pls find the JD as below.

Purpose of the role: Responsible for the Raw material/Packing material

Strategic:

1. Ensure 100% compliance to usage of Quality systems.

Operational:

• Adherence of cGMP (Current Good Manufacturing Practice) and cGLP (Current Good
• Laboratory Practice).
• Analysis of Raw material/Packing material/In-process samples in quality control department.
• Instrument/Equipment qualification in Quality control.
• Preparation and maintenance of quality records and study protocols.
• Preparation of quality system related, Instrument operation related SOPs, Specification, STPs,URS etc.
• Coordinating with cross functional team for the procurement of laboratory consumables, glasswares and chemicals etc.
• Handling of method transfer and method validation in quality control.
• Production process control in coordination with production.
• Handling of QMS elements related to quality control.
• Handling of laboratory incident reports.
• Maintenance and calibration of instruments in belongings to Quality control.
• Quality Interface in audits (both internal and external) and ensure appropriate QMS document identified in a timely manner and closed out.
• Analysis of vendor samples and reporting.Adherence of product specification.
• Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.
• To ensure readiness for Customer and regulatory audits.
• Quality Improvement Initiatives: Significantly contribute and deliver quality improvement initiatives within the organization in order to build and facilitate robust compliance.
• Providing the support to meet the management objectives of product deliveries on time in line with Quality Management system.
• Support quality related activities in other sites (as required).