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Quality Control Sr Supervisor (Technical Support & Compliance )

Pfizer


Location:
Ayer, MA 01432
Date:
11/25/2017
2017-11-252017-12-26
Pfizer
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Job Details

Location: Catania



Type of contract: permanent







**The Quality Control Sr Supervisor (Technical Support & Compliance ):**







Ensures that Quality Control methodology and procedures are developed, maintained and managed according to corporate, divisional and regulatory requirements to ensure product and process compliance.







**POSITION RESPONSIBILITIES**







The Sr supervisor, Quality Control (Technical Support & Compliance) , under routine supervision, is responsible for: Supervising and organizing personnel, systems and facilities in the laboratory under jurisdiction.



Supervises Quality Control Technical Support & Compliance unit:



Assigns and prioritizes projects among personnel to ensure that departmental schedules are met.



Serves as a technical resource, performing problem solving and trouble-shooting of laboratory procedures and systems.



Allocates manpower placement and supervises the utilization of facilities and equipment to ensure compliance.



Ensures training and development of employees:







+ Supervises and audits systems for the comprehensive training of area personnel.



+ Ensures proper documentation of personnel training.



+ Reviews and appraises the job performance of the employees. Recommending merit increases, promotions, transfers or other personnel actions.



+ Promotes initiative and stimulates leadership to consistently achieve results through others.







Interviews personnel for laboratory positions and make appropriate recommendations.



Trains employees in proper laboratory practices including good manufacturing practices and safety procedures; ensuring that employees understand and follow relevant Corporate, Divisional, Departmental, and Plant procedures.



Maintains Standard Test Procedure and Specification Manuals under jurisdiction up to date and informs personnel of changes.



Reviews Standard Test Procedures within area, writing new procedures, revising current procedures and evaluating procedures for accuracy and precision. Ensures that laboratory equipment is in good working order and that maintenance and calibrations have been performed.



Proposing modification to existing test methods, specifications or laboratory working papers where these are seen to be deficient or in need of revision. Qualification of equipment/ Lab automated system and maintaining the laboratory equipment Preventive Maintenance and Calibration Program.



Reviews and approve Laboratory investigations (is required).



Provides analytical/ microbiological technical support to the operational area. Responsible for transfer new analytical methods and technologies to the Laboratory.



Responsible for the development and validation of analytical/ microbiological methods and compendial methods.



Responsible for the evaluation of proposed changes to the Pharmacopoeias and the updates of the analytical test methods and specifications as per currents Pharmacopoeias.



Administers and safeguard the Laboratory Information Management System problem solving, debugging and implementing the full functionality of the LIMS system. Responsible for installation, validation and maintenance of the LIMS system.



Writes, updates and obtains approval of validation protocols/ reports as well as SOPs for the proper implementation, use, maintenance and change control of laboratory- automated systems. In coordination with the Business Technology (BT) Department, establish detailed system requirements for the subsequent development and/or acquisition of automated data processing system according to laboratory needs. Responsible for Data Integrity related to QC Department







**Organization of Personnel, Systems and Facilities :**



Establishes, revises and audits standard test times for use in derivation of manning and optimum utilization of employee resources. Analyzes the systems used to control the operations and recommends the adoption or revision of Departmental Procedures which will aid in meeting the laboratory objectives. Reviews the amount and type of equipment, instrumentation and facilities required and recommends appropriate work orders or purchase orders.







**Planning of Laboratory Activities :**



Plans the Laboratory operations so that schedules are met as efficiently as possible. Recommends continuous improvement initiatives.







**Assisting in Technical Problems :**



Develops reviews and approves reports in areas of technical expertise. Recommends analytical approaches and instrumentation to be used in solving technical problems. Provides guidance in the troubleshooting of test methods and technical coaching to laboratory personnel.







**Other Related Duties :**



Reviews changes in compendia and issues technical memos and reports. Enforces technical knowledge by attending seminars, short courses technical meetings and reviewing technical periodicals. Represents Company in outside professional activities. Assists Manager/ Team Leader, Quality Control in inter-laboratory projects and may assume Manager/ Team Leader, Quality Operations duties when absent. Must make a good faith effort to achieve Departmental Equal Opportunity Affairs (EOA) objectives and ensure personnel practices are fair and consistent with governmental requirements.







**EDUCATION AND EXPERIENCE**







+ Incumbents must possess a formal college education in chemistry or Industrial Chemistry, Pharmaceutical Technologies or Biology/Microbiology or other scientific degrees.



+ Experience in Production Operations, Quality Control, Quality Assurance & Compliance.



+ The incumbent must understand the working principles of complex instrumentation; be familiar with special techniques; and understand and implement procedures pertinent to laboratory operations.



+ Good knowledge of English.







J060







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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