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Quality Assurance Manager

Pfizer


Location:
Brooklyn, NY 11201
Date:
12/22/2017
2017-12-222018-01-22
Pfizer
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Job Details

**POSITION SUMMARY** :



This position will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities in Singapore, Clean Tech One site as follows:







+ Support and maintain quality systems such as laboratory investigations, deviation management, corrective and preventive actions (CAPAs), instrument qualifications and change management system.



+ Ensure quality systems are maintained consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.



+ Monitor systems to provide assurance that laboratory testing and transfer procedures, practices, process and operations are in compliance with applicable laws, rules, regulations, standards and specifications.



+ The review and approval of various types of laboratory documentation according to procedure requirements.



+ Perform lot release from Surveillance testing via Laboratory Information Management System (LIMS).



+ Review and Release Certificates of Analysis following certification of reference standards.



+ Provide oversight for administration of the training and document management systems. **ROLE RESPONSIBILITIES:**



+ Implement and ensure site quality systems are consistent with cGMPs, Pfizer policies, site procedures and regualtory guidance.



+ Implement and ensure surveillance and reference standard testing and transfers activities are conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.



+ Coordinate the notification to management process at SLS-Singapore



+ Provide quality oversight and guidance to ongoing laboratory investigations and deviations. Apply relevant analytical experience to solve technical problems in order to partner with the laboratories to identify root cause. Ensure that laboratory investigation reports and deviation reports are investigated, the information documented with sound scientific justification, adequate impact assessments are provided, appropriate root cause identified, meaningful correct/preventive actions proposed as established in the current procedures.



+ Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, analytical method validation protocols and reports, analytical method transfer protocols and reports, change control documentation, certificate of results, certificates of analysis, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements.



+ Create, track and approve corrective/preventative action items to help ensure they are completed with the agreed timeframes.



+ Perform internal/external audits as needed and provide timely feedback during the audit process. Assure adequate follow-up and resolution of external or internal audit findings and recommendations to SLS at Singapore Clean Tech One site and systems.



+ Perform lot release of surveillance samples via LIMS and/or other applicable system.



+ Provide QA release of Reference Standard Materials in the Reference Standard Database.



+ Provide support within SLS regarding training and document management systems



+ Participate in and take a leadership role with respect to quality assurance management team initiatives and objectives.



+ Work together with the SLS management to assure that objectives and metrics are met.



+ Actively participate in the SQRT process.



+ Support the development of SLS right first time initiatives and procedures along with the communication of associated quality metrics.



+ Support in the evaluation of resources (people, materials, and facilities) and skills to assure site compliance. **QUALIFICATIONS**



+ B.S. Degree in Pharmacy or Chemistry or related field with 10 years experience working in a Quality Assurance or Quality Control Supervisor role supporting pharmaceutical manufacturing or an analytical testing laboratory.



+ M.S. Degree or higher in Pharmacy or Chemistry or related field with 5-7 years experience working in a Quality Assurance or Quality Control Supervisor role supporting pharmaceutical manufacturing or an analytical testing laboratory.



+ Previous Quality Control and/or Quality Assurance in API/Drug Product facility is required. **PHYSICAL/MENTAL REQUIREMENTS**



+ Must possess excellent written and oral communication skills, organizational skills, customer service/team oriented attitude, ability to work independently, ability to effectively manage a team and multiple projects.



+ Strong knowledge of FDA / Global cGMP Regulatory Agency requirements.



+ Knowledge in HSA, DEA, OSHA, ICH guidance and EPA regulations applicable to the pharmaceutical industry.



+ Must be comfortable interacting with all levels of management in the PGS organization. **NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Ability to travel an estimate of 5-10%.



+ Some over time and weekend support may occasionally be required.







Flexi Work - SLS (Singapore)



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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