Pfizer recruitment 2019-Apply online: Pfizer is inviting eligible candidates to apply online for the position of Sr. Specialist – Complaints & APQR . Candidates can find their eligibility from below details .Eligible and interested candidates can apply from the source may provided at the bottom of this article. This content to be used only for informational purpose and not responsible for the inaccuracy or deficiency of the provided information.
Experience required:1+ years
Post Name: Sr. Specialist – Complaints & APQR
Job Description:Apply knowledge of applicable regulations and guidelines (FDA 21CFRs, ICH, EU, ISO, cGMP) to assure adherence to company, industry, and governmental standards. Prepare and monitor complaints trend for frequency of product complaint types, provide interpretations, and draw conclusions at the site level. Applies skills and discipline knowledge to contribute to the achievement of work within work team Prepare AQRT Executive Summary reports for significant complaints/deviations and coordinate reviews and meetings. Prepare Initial/Follow-up/Final Field Alert Reports (FAR) as required and coordinate off-site reviews, on-time submission with SQOL. Review & approval of complaint investigations/mock market actions. Review Annual Product Quality Review (APQR) summary reports and annual schedule. Identify system improvement opportunities for data gathering, template content/format, process efficiency and ensure progress of APQR data collection Review, approval and verification of Corrective Action and Preventive Actions resulting from Complaints/APQRs. Conduct walkthrough audits and quality system based audits, when required. Generate complaints and APQR metrics and trends to S-QRT. Ensure cGMP compliance of all Standard Operating Procedures (SOP)/Quality Management System (QMS) Engage to continuous knowledge development regarding rules, regulations, best practices, and performance standards in pharmaceutical industry. Active involvement in development, implementation, maintenance and continuous improvement of Complaint Investigations & APQR Reports Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Location:India – Vizag
No of Vacancy:NA
Opening Date: 31-05-2019
About Company :Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.