Cipla BPharma QA Job Opening, Apply Online
Cipla BPharma QA Job Opening, Apply Online. B Pharma Junior Team Member – QA job opening 2023. B Pharma job opening 2023, Cipla Ltd job opening 2023, B Pharma job opening 2023. Interested and eligible candidates may check out all the details
Possible Interview Questions for the role of Junior Team Member – QA at Cipla are posted below
Job Title: Junior Team Member – QA (77191)
Division: Quality
Department: Quality
Employment Type: Permanent
Job Purpose: Review the compliance level of site for deficiency response, 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 in order to respond to regulatory authorities in a timely manner
- Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies
- Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
- Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
- Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
- Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
- Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements
- Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning
- Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
- Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements
- Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction
Education Qualification: B. Pharma/ M.Sc
Relevant Work Experience: 2 years of experience in the quality assurance department
Competencies/Skills
- Communication Skills (clarity of thought, comprehension)
- Likely potential for growth
- Job / Product / Technical Knowledge / Pharma domain knowledge
- Presentation & Interpersonal skills (If applicable)
- Managerial or People Management skills
- Safety awareness (If applicable)
- Relevance of Previous Experience
- Comprehension, Analytical & Problem solving abilities
- Productivity & Result Orientation (If applicable)
- Attitude
- Qualification fitment
- Sales drive (If applicable)
- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.
Possible Interview Questions for the role of Junior Team Member – QA at Cipla:
- Can you provide an example of a deficiency response you have worked on in the past? How did you collate, review, and provide work plans to address the deficiencies? (Answer should include discussing the process followed, coordination with relevant stakeholders, and adherence to timelines.)
Answer: In my previous role, I encountered a deficiency response related to batch documentation. I collated the deficiencies, reviewed each one, and prepared a work plan outlining the necessary actions to address them. I coordinated with the relevant departments to ensure timely execution of the work plan and submitted the response within the required timeframe.
- Describe your experience in reviewing master validation protocols and reports. How did you ensure timely execution of validation batches and submission of necessary documents to address deficiencies? (Answer should cover the steps taken, coordination with teams, and adherence to regulatory guidelines.)
Answer: During my previous role, I was responsible for reviewing master validation protocols and reports. I ensured timely execution of validation batches by closely coordinating with the manufacturing team and monitoring progress. I also reviewed the necessary documents to address any deficiencies identified during the validation process, ensuring compliance with regulatory guidelines.
- How have you contributed to the annual product quality review process in your previous role? Discuss how you ensured completeness and data correctness to meet cGMP requirements and prepare for audits. (Answer should highlight involvement in the review process, attention to detail, and adherence to cGMP requirements.)
Answer: In my previous role, I actively participated in the annual product quality review process. I reviewed the reports, paying close attention to completeness and data correctness. I ensured compliance with cGMP requirements by verifying the accuracy of the data and supporting documentation. Additionally, I prepared the necessary reports to demonstrate audit readiness and adherence to quality standards.
- Can you share an example of your involvement in issuing regulated market technical agreements? How did you ensure the execution of batches according to customer requirements? (Answer should include the process followed, communication with customers, and maintaining documentation.)
Answer: In my previous position, I was responsible for issuing regulated market technical agreements. I collaborated closely with the customers to understand their specific requirements and ensured the execution of batches aligned with those requirements. I maintained clear documentation of the technical agreements and communicated any changes or updates to the relevant teams to guarantee smooth execution.
- How have you contributed to regulatory and customer inspections/audits at your previous site? Describe your role in meeting regulatory expectations and acquiring GMP approvals. (Answer should demonstrate involvement in inspection/audit processes, coordination with internal teams, and ensuring compliance with regulatory requirements.)
Answer: In my previous role, I actively participated in regulatory and customer inspections/audits at our site. I collaborated with auditors and various internal teams to prepare for the inspections, ensuring compliance with regulatory expectations. I facilitated the implementation of corrective actions based on audit findings and worked towards acquiring GMP approvals. By closely adhering to regulatory requirements and maintaining effective communication, we successfully met regulatory expectations.
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