Executive QA

We are looking for a dynamic and motivated Executive QA to join our R&D team. This role offers an exciting opportunity to enhance your expertise in the field of monoclonal antibodies (mAbs) and protein biosimilar.

The Quality Assurance professional would play a major role to ensure compliance with regulatory standards. The role involves documentation, audits, validations, and continuous improvement of quality systems.

Key Stakeholders:

Experience:

Role & Responsibilities:

• Issuance, archival and retrieval of documents

• Issuance of Control copies to respective dept

• Preparation and tracking of all QA documents.

• Maintaining of backup of QA softcopies.

• Maintaining SOP/s with proper indexing.

• Preparation and review of SOPs.

• Management of QA stationary (controlled copies and logbooks)

• Dispatch and line clearance activities.

• Involving in handling of deviations, change control and related CAPAs

• To ensure data integrity compliances while performing activities.

Competencies:

• Quick learner with excellent communication skills
• Punctual with proven track record of dedication & reliability
• A team player who is equally capable of working alone
• Fluent in both written and spoken English
• Knowledge /Experience in handking QA aspects for biosimilars and rproteins projects