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Senior Associate Manufacturing Compliance

6.00 to 8.00 Years   Hyderabad   08 Nov, 2021
PFIZER LIMITED
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

JOB RESPONSIBILITIES

  • Ensure compliance to GDP and ALCOA Principles during document preparation. Initiation and closure of the production related Change controls Tracking and implementation of production CAPAs. Responsible for the CCF initiation, coordination with CFT for impact assessment and CCF pre-approval, responsible for closure of CCF. Procedural Updation as per approved CCF and ensuring PLS upload. Monitoring of action items addressed in the CCF and closure as per the timelines mentioned in CC Interact with investigator for CAPA plan and support in investigation. Knowledge on AMPS and PDOCS systems commonly used in manufacturing areas. Well versed with Microsoft word, excel and power point presentation. Good Knowledge on regulatory guidelines. Knowledge on ALCOA principles.Drive cross-functional engagement on site risk initiatives including the development and management of a local risk plan and register Ensure compliance to Pfizer Global Quality Systems during QRM preparation. Coordinate, plan, and facilitate risk management efforts for manufacturing equipment s and process. Provide technical expertise as needed and work with colleagues across the site as part of the cross functional QRM preparation. Support cross functional team for robust impact assessment and effective risk mitigation planning Drive and promote the Pfizer values within the workplace. Escalation and communication of risks through the established site governance and escalation processes. Ensure that schedule-based risk reviews occur at specified time periods.
Qualifications
  • Masters Degree
  • 6 years experience
  • Good technical writing skills, and communication as well as presentation skills
  • Working knowledge of Microsoft Office, Microsoft Project, Statistical Software.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control #LI-PFE,

Keyskills :
customer relationsinsurancequalitysalesmisequal employment opportunityenvironmental impact assessmentcontinuous improvement facilitationon siterisk reviewswriting skillsmicrosoft wordrisk management

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