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MQA Sr. Specialist - Upstream

8.00 to 10.00 Years   Vishakhapatnam   02 May, 2021
PFIZER LIMITED
Job LocationVishakhapatnam
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC),Bio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

Experience - 8 to 10 Years of Experience in Pharmaceutical industryQualification: M. Pharm / B. Pharm / M.Sc (Any Specialization)

  • Review & approval of Master data, Work flows, Master Recipes, Master recipe Configuration documents (MRCD), Business verification (BV) scripts, Signature strategy/Signature Policy documents, and Baseline configuration document (BCD)
  • To Provide training on AMPS Master Recipe, Master Workflows, Master Data, EBR review and release to MQ colleagues.
Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling and capping operations. Maintain regulatory compliance in accordance with cGMP practices.Ensure manufacturing policies and procedures conform to Pfizer standards. Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from supervisor.Review of batch reports and equipment audit trails. Perform EMS alarm impact assessments and monthly trend reports.Ensure start-up and in-process activities performed as per batch record and SOP compliance. Monitor and adherence manufacturing practices with respective standards and approved procedures.Perform daily walk throughs and report observations to the supervisors and ensure appropriate closer of those incidents. Perform equipment breakdown assessments w.r.t to product quality and patient safety independently.Review and approval of equipment alarms and review of alarm trends. Report any non-compliance to the supervisor. Responsible for performing manufacturing investigations, implementation of CAPAs and to approve investigation and CAPAs.Manage investigation and apply relevant and necessary actions/ systems to ensure appropriate closure of those incidents. Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.Experience in handling regulatory, corporate and internal auditors / inspectors. Responsible for assisting manufacturing investigators w.r.t collection of data, information and technical support and may perform in conducting investigations.Ensure that reports are aligned with regulatory requirements, site standards procedures an company policies. May lead a team of MQA colleagues on an interim basis in the absence of the supervisorPfizer 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 :
product qualitytechnical supportquality assuranceregulatory compliancelegislative relationsregulatory requirementssopebrcgmpampscapasalarmsems

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