Sr. Associate -Quality Review
- Pfizer
- 3 - 4 years
- Visakhapatnam
- 5 days ago
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Job Description
Experience: 6 - 8 years of experience in Quality Assurance / Quality control of sterile dosage manufacturing facility.
Core Competencies
- Change Management process
- Risk assessments principles and tools
- Validation of lab equipment s
- Drug Product Process validations
- Regulatory requirements
- Compendial Changes
Technical Skills
- Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications.
- 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
- Knowledge on Chemical and Microbiology analysis.
- Basic idea on manufacturing operations, validation and engineering functions
- Experience in handling Regulatory agency inspections
Behavioral/Any Other Skills
- 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, strong time management skills.
- Acts Decisively: Makes decision in a timely manner based on available information
- Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
- Self-accountable & Proactive approach
- Critical thinking and Compliance mindset
Core Responsibilities
- Partially/fully independent, reviews critical change controls and protocols, trains others.
- Responsible for review & approval of documents as per current regulatory requirements.
- Assessment, approval & closure of change control and action items
- Site change review committee (SCRC) meeting with cross functional team to assess the change before initiation in gqts and present the critical change controls to the leadership team for its adequacy.
- Coordinating with CFT for addressing & resolving of Review Comments for timely Closure.
- Review & approval of Sops, Job aids, forms, Quality Risk Assessment (QRA), validation protocols, study protocols & summary reports.
- Review and approval of STP s and specifications.
- Review and approval of stability compilation reports.
- Review and approval of APR s.
- Review and approval of Environmental monitoring trends, Water monitoring trends, bioburden, BET, sterility trends, isolate trends and summary reports.
- Ensure manufacturing policies, procedures conform to Pfizer
- Report any non-compliance to the Manager
- Experience in handling regulatory, corporate and internal auditors/ inspectors.
Work Location Assignment: On Premise
Quality Assurance and Control
#LI-PFE
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: Change management Manager Quality Assurance Microbiology Technical writing Risk assessment Manager Quality Control Environmental monitoring Manufacturing operations STP Water system
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