Job Title: Junior Team Member – Quality Assurance
Company: Cipla
Location: Goa
Qualification: B. Pharma/M.Sc
Experience: 2 years in Quality Assurance
Salary: Not disclosed
About Company:
Review the compliance level of the site for deficiency response, prepare master validation protocol, and report as per company quality policy and applicable regulatory guidelines.
Accountabilities:
| Tasks | Details |
|---|---|
| Compliance Review | Collate, review, and provide work plans on received deficiencies to the Head Office for timely regulatory responses. |
| Validation Protocol | Review Master Validation protocol and report for timely execution and submission of validation batches. |
| Annual Product Quality Review | Ensure completeness and data correctness to comply with cGMP requirements and audit readiness. |
| Technical Agreements | Maintain and issue regulated market technical agreements for batch execution per customer requirements. |
| Documentation | Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports for new products. |
| Audit Coordination | Coordinate with auditors and site teams for regulatory and customer inspections to meet expectations and acquire GMP approvals. |
| Compliance Drafting | Prepare final draft of compliance to audit observations, ensuring alignment with cGMP requirements. |
| Data Compilation | Collect, compile, and review raw data for timely submission of MHRA, UK interim update documents. |
| Continuous Improvement | Drive initiatives in CQA to facilitate adherence to cGMP. |
| Legal Submissions | Review product licenses, certificates, staff approvals, and other applications for on-time, error-free submissions. |
| Inspection Support | Support in CDSCO and state FDA inspections to achieve GMP compliance and secure product licenses and approvals. |
Competencies/Skills:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management