Company
Pharma / Biotech
Sr.AssociateQualityAssurance
Neural analysis suggests this role is
optimal for Mid candidates.
“Sr. Associate Quality Assurance. Skills: Quality Assurance, cGMP, GxP, Validation, Change Management, Risk assessments. Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.. Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.”
What You'll Achieve.
Ensure compliance with established specifications.; Identify deviations from standards.; Maintain compliance with configuration management policies.; Ensure regulatory compliance with current Good Manufacturing Practices (GxP); Meet global regulatory and Pfizer quality standards.
Industry & Context.
Critical thinking; Persistent approach to resolving issues
What They're Looking For.
Must Have
Bachelor's Degree in Sciences/ Pharmacy with Minimum 6 to 8 years in Pharma/ Biotech, Master's Degree in Sciences/ Pharmacy with Minimum 5 to 7 years in Pharma/ Biotech, Change Management process, Risk assessments principles and tools, Validation of manufacturing equipment’s, Drug Product Process validations, Regulatory requirements
Nice to Have
Interpersonal skills, Ability to communicate effectively with all levels within the organization., Compliance driven approach, knowledge on cGMP and regulations., Knowledge in validation principles and practices related to the Equipment & Utility Qualifications, Water system, HVAC system., Understanding of Drawings and layouts of manufacturing area, air flow, material flow, personal flow, building management system for real-time monitoring of manufacturing areas., Fundamental knowledge on manufacturing activities like dispensing, solution preparation, filling, terminal sterilization, visual inspection, labelling and packing., Understanding of design and engineering aspects, basic knowledge of equipment construction, working principle and maintenance of equipment., Knowledge of various Quality tools required for investigations, Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization., Knowledge in Change control assessment, Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship., Managerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, time management skills., Written communication: Ability to write well-Structured technical reports., Holds people accountable: Clearly assigns responsibility for tasks and sets clear objectives and Monitors process, progress and results, Acts Decisively: Makes decision m a timely manner based on available information., Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives, Grows others: Provides challenging and stretching tasks and assignments., Self-accountable & Proactive approach., Critical thinking and Compliance mindset.
What You'll Do.
Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
Approve investigations and change control activities to maintain compliance with configuration management policies.
Contribute to moderately complex projects
managing time effectively and developing short-term work plans.
Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
Investigate and document Quality Assurance deviations
escalating issues to the Quality Assurance Lead as needed.
Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
How You'll Work.
Team & Collaboration
Ability to communicate effectively with all levels within the organization.; Effective communication with all staff from different levels and builds constructive and effective relationship.
Communication Scope
Ability to communicate effectively with all levels within the organization.; Effective communication with all staff from different levels and builds constructive and effective relationship.; Written communication: Ability to write well-Structured technical reports.
Process & Methodology
Managing time effectively, Developing short-term work plans, Time management skills
Full Job Description
**Use Your Power for Purpose** Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. **What You Will Achieve** In this role, you will: * ## Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications. * ## Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. * ## Approve investigations and change control activities to maintain compliance with configuration management policies. * ## Contribute to moderately complex projects, managing time effectively and developing short-term work plans. * ## Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. * ## Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. * ## Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. **Here Is What You Need**(Minimum Requirements) * ## Bachelor's Degree in Sciences/ Pharmacy with Minimum 6 to 8 years in Pharma/ Biotech / Master's Degree in Sciences/ Pharmacy with Minimum 5 to 7 years in Pharma/ Biotech * ## Change Management process * ## Risk assessments principles and tools * ## Validation of manufacturing equipment’s * ## Drug Product Process validations * ## Regulatory requirements **Bonus Points If You Have**(Preferred Requirements) * ## Strong Interpersonal skills * ## Ability to communicate effectively with all levels within the organization. * ## Compliance driven approach , knowledge on cGMP and
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