Pfizer Pharmaceutical Chemistry Job Vacancy – Apply Online
Dont forget to check out possible interview questions for this job below
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Job Title: Sr. Associate – I, CDM
Location: India – Chennai
Eligbility Criteria & Skills:
- Academic Degree: Professional in Pharmaceutical Chemistry or equivalent
- Regulatory knowledge and experience (at least 2-5 years)
- Demonstrated ability to work in a highly regulated environment
- Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
- Functional and technical knowledge and skills to do the job at a high level of accomplishment
- Proven technical aptitude
- Quick learner with ability to multi-task
- Ability to work with accuracy and attention to detail
- Ability to work with autonomy and/or part of a team in a busy environment
- Demonstrated ability to work in a highly regulated environment
- Quality focus
- Customer orientation
- Analysis and solution of problems
- Effective communication
- English intermediate to advance (written and spoken)
- Proven ability to coach and mentor others
- Proven ability to oversee and QC others work
- Ability to effectively communication with Regulatory professionals in other countries
Project Management Experience
Job Responsibilities:
- Review and interpret the data provided by the PCO to establish the system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope.
- Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope.
- Review audit reports from the systems and resolve errors to ensure integrity of data
- Identifies issues and provides input into solutions
- Accountable for remediation efforts associated with their scope as part of SCC global rollout.
- Perform monthly PEARL compliance report review and complete remediation activities in close partnership with Regulatory strategist teams
- Adhering to quality control procedures and standards related to the systems or tools ensuring Regulatory Compliance
- Support global/local team members with data management workload when necessary to provide flexible support for the portfolio.
- Adhere to Pfizer compliance standards
- Act as Regulatory Data SME in regions supported
- Produce country/regional reports as required
- Support audit as part of regulatory data / system scope
- Contributes to the completion of moderately complex projects as needed
- Has strong knowledge/understanding of the principles and concepts of the discipline.
Job Summary
This role will work within a team whose main focus will be to interpret the regulatory data received across different geographies, functions, divisions and ensuring key activities and regulatory systems updates are completed whilst adhering to all policies, practices and procedures. Timeliness/ accuracy in the data entry and removal of workload associated with data entry from Regulatory Strategy teams will be key performance indicators for this role. These activities ensure data integrity to enable the organization to have visibility across all functions within a products lifecycle. It is essential that all systems are clearly and accurately updated within the timelines specified in the Standard Operating Procedures (SOP) or business process documentation to ensure regulatory compliance.
Apply Online
Possible interview questions and answers for the above post:
- What is your experience with regulatory knowledge and working in a highly regulated environment?
Answer: I have over 5 years of experience working in a highly regulated environment with a strong understanding of regulatory knowledge in the pharmaceutical industry. I have experience with regulatory data interpretation and data management, which will be beneficial for this role.
2. How do you ensure accuracy and attention to detail in your work, especially when dealing with multiple tasks simultaneously?
Answer: I have a systematic approach to managing multiple tasks and prioritize tasks based on their importance and deadline. I double-check my work to ensure accuracy and attention to detail. Additionally, I ensure that I have a clear understanding of the requirements before starting any task.
3. What experience do you have with project management?
Answer: I have experience with project management and have been responsible for overseeing the completion of moderately complex projects in my previous roles. I have experience with project planning, execution, monitoring, and control, which will be beneficial for this role.
4. How do you ensure regulatory compliance while adhering to the standard operating procedures (SOPs) or business process documentation?
Answer: I ensure regulatory compliance by adhering to the SOPs or business process documentation while performing my duties. I review and interpret the data provided by the PCO to establish the system/tools required to be populated, ensuring that all systems are clearly and accurately updated within the timelines specified in the SOPs or business process documentation.
5. How do you handle issues that arise in your work and provide input into solutions?
Answer: I handle issues by identifying the root cause and brainstorming potential solutions with the team. I communicate effectively with the team to ensure that we have a clear understanding of the problem and work collaboratively to find the best solution.
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