ROLE SUMMARY

　　This position will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities in Chennai, India. Some support for other SLS sites may also be necessary. Has the role of maintaining quality systems such as laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management. Distribute notifications outside of SLS regarding Out of Specification/Questionable testing results. Ensure SLS quality systems are maintained consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance. Assures that stability testing/administration, reference standard testing & distribution and analytical method validation and transfer procedures, practices, process, and operations follow applicable laws, rules, regulations, standards and specifications. Review and approval of laboratory investigations, analytical method validations and transfers, laboratory instrument calibration and quality alerts according to procedural requirements.

　　ROLE RESPONSIBILITIES

　　Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) laboratory investigation reports, deviation reports, analytical method validation and transfer reports, change control documentation, certificate of results, laboratory instrument qualification/calibration and quality alerts according to procedure requirements.Distribute Issue escalations to customers. Management of documentation library (as applicable).Vendor management support.Support external audits of SLS through activities such as scribing and coordinating document retrieval/review.Ensure site quality systems are consistent with cGMPs, Pfizer policies, site procedures and regualtory guidance.Able to apply relevant analytical experience to solve technical problems in order to partner with the laboratories to identify root cause .Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry. Experience with the principles and application of quality risk management. Work together with the SLS management to assure that objectives and metrics are met.Contribute to quality assurance management team initiatives and objectives.Create, track and approve corrective/preventive action items to help ensure they are completed within 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 findingsDrive the development of SLS right first time initiatives, SQRT presentations and procedures along with the communication of associated quality metrics.Communicate with other Pfizer sites and suppliers/ contractors external to Pfizer to support business processes and to benchmark on best practices.Ensure stability testing/administration, reference standard testing & distribution and analytical method validation and transfers activities are conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.

　　BASIC QUALIFICATIONS

　　Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience. 3+ years' experience in QA/pharmaceutical industry.Demonstrated experience and skills in conduct and documentation of quality investigations related to pharmaceutical / medical device manufacturing processes.Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validations, engineering drawings and basic statistical processes.Ability to understand and apply towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability.Good technical writing skills, and communication as well as presentation skills.Working knowledge of Microsoft Office, Microsoft Project, Statistical SoftwareExperience writing and managing deviations.

　　PREFERRED QUALIFICATIONS

　　Experience at a pharmaceutical manufacturing site.Experience in investigation of non-conformance, root cause analysis and change control management.Drug stability study management experience8 to 12 ye

　　ROLE SUMMARY

　　This position will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities in Chennai, India. Some support for other SLS sites may also be necessary. Has the role of maintaining quality systems such as laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management. Distribute notifications outside of SLS regarding Out of Specification/Questionable testing results. Ensure SLS quality systems are maintained consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance. Assures that stability testing/administration, reference standard testing & distribution and analytical method validation and transfer procedures, practices, process, and operations follow applicable laws, rules, regulations, standards and specifications. Review and approval of laboratory investigations, analytical method validations and transfers, laboratory instrument calibration and quality alerts according to procedural requirements.

　　ROLE RESPONSIBILITIES Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) laboratory investigation reports, deviation reports, analytical method validation and transfer reports, change control documentation, certificate of results, laboratory instrument qualification/calibration and quality alerts according to procedure requirements.Distribute Issue escalations to customers. Management of documentation library (as applicable).Vendor management support.Support external audits of SLS through activities such as scribing and coordinating document retrieval/review.Ensure site quality systems are consistent with cGMPs, Pfizer policies, site procedures and regualtory guidance.Able to apply relevant analytical experience to solve technical problems in order to partner with the laboratories to identify root cause .Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry. Experience with the principles and application of quality risk management. Work together with the SLS management to assure that objectives and metrics are met.Contribute to quality assurance management team initiatives and objectives.Create, track and approve corrective/preventive action items to help ensure they are completed within 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 findingsDrive the development of SLS right first time initiatives, SQRT presentations and procedures along with the communication of associated quality metrics.Communicate with other Pfizer sites and suppliers/ contractors external to Pfizer to support business processes and to benchmark on best practices.Ensure stability testing/administration, reference standard testing & distribution and analytical method validation and transfers activities are conducted in a manner consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance. BASIC QUALIFICATIONS Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience. 3+ years' experience in QA/pharmaceutical industry.Demonstrated experience and skills in conduct and documentation of quality investigations related to pharmaceutical / medical device manufacturing processes.Strong knowledge and understanding of Quality System functions, manufacturing / packaging processes, validations, engineering drawings and basic statistical processes.Ability to understand and apply towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability.Good technical writing skills, and communication as well as presentation skills.Working knowledge of Microsoft Office, Microsoft Project, Statistical SoftwareExperience writing and managing deviations.PREFERRED QUALIFICATIONSExperience at a pharmaceutical manufacturing site.Experience in investigation of non-conformance, root cause analysis and change control management and stability testing.Drug stability study management experience8 to 10 years in the quality assurance area.

　　Work Location Assignment: On Premise

　　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