Junior QA Role at Cipla – BPharma Apply Online
Junior Team Member – QA
Posting Date: 24 Oct 2024
Country: India
State: Sikkim
Location: Rangpo
Req Id: 89235
Division: Quality
Department: Quality
Employment Type: Permanent
Job Purpose
Review the compliance level of the site for deficiency response, and prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines.
Accountabilities
- Collate, review, and provide required work plans on received deficiencies to HO to respond to regulatory authorities in a timely manner.
- Review Master Validation protocol and report for timely execution of validation batches and submission of documents to respond to deficiencies.
- Review annual product quality review reports at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness.
- Review, upkeep, and issue regulated market technical agreements at the site for executing batches per customer requirements.
- Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at the unit for the smooth execution of new products.
- Coordinate with auditors and site teams for regulatory and customer inspections/audits at the site to meet regulatory expectations and acquire GMP approvals.
- Prepare the final draft of compliance to audit observations and ensure alignment with cGMP requirements to avoid regulatory action and promote continual improvements.
- Collect, compile, and review raw data and finalize for timely submission of MHRA, UK interim update documents to corporate, tracking interim updates at a site level for risk-based inspection planning.
- Drive continuous improvement initiatives in CQA to ensure adherence to cGMP.
- Ensure timely and error-free submissions by reviewing product licenses, certificates for product registration, tender documents, staff approvals, and other applications to adhere to legal requirements.
- Support CDSCO and state FDA inspections for GMP compliance and product licensing, facilitating FDA staff approvals through cross-functional interaction.
Education Qualification
- B. Pharma / M.Sc
Relevant Work Experience
- 2 years of experience in the quality assurance department
Competencies/Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location: Rangpo
If you are interested in this position, please apply here.
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