Executive QA

3 days ago

Nagpur India GeNext Genomics Pvt Ltd Full time

Job Description

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

The Quality Assurance professional would play a major role to ensure compliance with regulatory standards, Good Manufacturing Practices (GMP), and company policies to maintain the highest quality of biopharmaceutical products. The role involves documentation, audits, validations, and continuous improvement of quality systems.

Responsibilities

- Issuance, archival and retrieval of documents

- Issuance of Control copies to respective dept

- Destruction of the GMP documents once the retention term has passed and controlled copies of the obsolete GMP documents.

- 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

Qualifications

M.Sc or M.Pharma with Regulatory and Documentation as expertise

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