Sanofi B Pharma/M Pharma Recruitment – Quality Assurance
Dont forget to check out possible interview questions for this job below
Sanofi hiring pharmacy candidates. Pharmacy job opening 2023. M Pharma job opening 2023. Pharma job opening 2023. Executive Quality Assurance job opening 2023. Candidates having graduate and postgraduate degrees in pharmacy may apply for the job opening at Sanofi
Job Title: Executive Quality Assurance
Education: B. Pharma / M. Pharma
Languages: English / Hindi
Experience: (avoid asking for a minimum number of years of experience) 3 to 5
- Must be able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions
- Must have global view, able to understand the impact of the decision on other company functions.
- Knowledge of GMP and regulatory requirements
- Skilled in teamwork
- Understands IA Global organization and related processes
In-Process Quality Assurance [IPQA]
- Review of Master Batch Records & executed Batch Records
- Review of logbooks.
- Line clearance in Production.
- To perform In-process checks in Production.
- Sampling of products during routine production and validation.
- Quality oversight on shopfloor.
- Quality Management Systems
- Compilation and Review of Product Quality Reviews.
- Review of GxP documents, batch manufacturing record and batch packing record in electronic-document system.
- Implementation of quality documents, management, and control of documents, such as SOPs, Master Documents etc.
- Initiation, implementation, and closure of change controls.
- Initiation of deviation and support in deviation investigation.
- Support in Market Complaint investigation.
- Implementation of assigned CAPAs and support in closure.
Validation & Qualifications
- Quality focal point for all validations [Process, cleaning, transport & computerized system] and qualification activities.
- Quality focal point for temperature/ relative humidity mapping activities.
- Quality focal point for study related to hold time of products, cleaned/uncleaned equipment hold time, campaign length.
Important Interview Questions and Answers for the above job role:
- Can you tell us about your experience with In-Process Quality Assurance (IPQA) and how you ensure quality oversight on the shop floor?
- Answer: In my previous role, I was responsible for reviewing Master Batch Records and executed Batch Records, performing in-process checks in Production, and sampling products during routine production and validation. To ensure quality oversight on the shop floor, I ensured that line clearance in Production was done properly and reviewed logbooks to ensure compliance with GMP and regulatory requirements.
- How do you ensure compliance with quality management systems and regulatory requirements when reviewing GxP documents, batch manufacturing records, and batch packing records?
- Answer: As an Executive Quality Assurance, I compile and review Product Quality Reviews and ensure the implementation of quality documents such as SOPs and Master Documents. I initiate, implement, and close change controls, as well as deviations and support in deviation investigation. I also support Market Complaint investigation and the implementation of assigned CAPAs to ensure compliance with quality management systems and regulatory requirements.
- Can you give an example of a complicated technical issue you had to present to stakeholders and how you obtained appropriate actions?
- Answer: In a previous role, I had to present the impact of a quality issue on other company functions. I presented the technical issue in an easy and understandable manner by using visual aids and avoiding technical jargon. I also provided possible solutions and collaborated with stakeholders to obtain appropriate actions.
- How do you ensure effective communication and teamwork when working on validation and qualification activities?
- Answer: As a Quality focal point for all validations and qualification activities, I ensure effective communication and teamwork by establishing clear roles and responsibilities, providing regular updates on progress, and facilitating discussions and feedback sessions. I also encourage open communication and constructive feedback to foster a positive working environment.
- How do you ensure a global view and understand the impact of your decisions on other company functions?
- Answer: As an Executive Quality Assurance, I ensure a global view by staying updated on industry trends and regulations, and by collaborating with stakeholders from different departments and regions. I also consider the impact of my decisions on other company functions by conducting risk assessments, analyzing data, and seeking feedback from stakeholders.
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