About this Job Opportunity at Bommasandra, Cipla
Here’s a quick overview of this job opportunity at Cipla in Bommasandra.
- Role: Junior Team Member – QA
- Requisition ID: 79080
- Division: Quality
- Department: Quality
- Employment Type: Permanent
- Location: Bommasandra, Karnakataka
Table of Contents
Job Purpose
The main purpose of this role is to review the compliance level of the site for deficiency response, prepare master validation protocols, and report as per the company’s quality policy and applicable regulatory guidelines.
Accountabilities
- Deficiency Response: Collate, review, and provide required work plans on received deficiencies to HO (Head Office) to respond to regulatory authorities in a timely manner.
- Master Validation Protocol: Review the Master Validation protocol and report for the timely execution of validation batches and the timely submission of documents in response to deficiencies.
- Product Quality Review: Review the annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness.
- Technical Agreements: Review, upkeep, and issue regulated market technical agreements at the site for the execution of batches as per customer requirements.
- Document Handling: Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at the unit for the smooth execution of new products.
- Regulatory Inspection: Coordinate with auditors and site teams for regulatory and customer inspections/audits at the site to meet regulatory expectations and acquire GMP approvals.
- Audit Compliance: Prepare the final draft of compliance to audit observations and check whether it is in line with cGMP requirements to avoid regulatory action and promote continual improvements.
- Document Compilation: Collect, compile, and review raw data and finalize the same for the timely submission of MHRA, UK interim update documents to corporate as per agency requirements. Track interim updates at a site level for risk-based inspection planning.
- Continuous Improvement: Drive continuous improvement initiatives in CQA (Corporate Quality Assurance) to facilitate adherence to cGMP.
- Regulatory Submissions: Execute on time and errorless submissions by reviewing product licenses, all certificates for product registration and tender, staff approvals, and other applications to adhere to legal requirements.
- Inspection Support: Support in CDSCO (Central Drugs Standard Control Organization) and state FDA inspection to be GMP compliant and obtain product licenses, FDA stall approvals by ensuring cross-functional interaction.
Educational Qualification
Candidates should have a B. Pharma or M.Sc. degree.
Relevant Work Experience
2 years of experience in the quality assurance department.
Competencies/Skills
- Effective communication skills (clarity of thought, comprehension)
- Demonstrated potential for growth
- Job/Product/Technical Knowledge/Pharma domain knowledge
- Presentation and interpersonal skills (if applicable)
- Managerial or people management skills
- Safety awareness (if applicable)
- Relevance of previous experience
- Strong comprehension, analytical, and problem-solving abilities
- Emphasis on productivity and result orientation (if applicable)
- Positive attitude
- Qualification fitment
- Sales drive (if applicable)
- Desirable personality traits (individualistic/team player, outspoken, maturity, etc.)
Job Location
Bommasandra, Karnakataka
Shift Hours
As per company requirements
About Cipla
Cipla, a renowned pharmaceutical company committed to providing accessible healthcare solutions, is seeking dynamic individuals to join their manufacturing division as Junior Officers. This position offers a unique opportunity to contribute to the production process and ensure the highest standards of quality and safety.
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