Job Focus:
Maintains QC laboratory performance by establishing quality standards and ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Pfizer Quality and regulatory standards.
Academic Qualification:
Master’s in Pharm D and Chemical Sciences from a reputable and recognized university.
Professional Experience:
Minimum 05 to 7 years relevant experience on supervisory role in any reputable pharmaceutical organization.
Skills & Competencies:
Personal:
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Good command of written and spoken English.
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Knowledgeable with interpersonal learning
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Communication, teaching and coaching skills
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Management and decision-making skills
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Competent in analytical skills
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PC literate with the following applications: MS Excel, Word, PowerPoint
Technical:
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On hand experience for all laboratory instruments and Qualification.
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Ability to read English and interpret documents such as cGMP/ FDA regulations, standard operating procedures, and Pfizer corporate policy manuals.
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Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
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Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems.
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Excellent attention to detail and time management skills.
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Ability to work independently and with work teams.
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On hand experienced on all laboratory instrument and techniques.
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Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks in line with corporate objectives.
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You are flexible and have a "can-do" attitude
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Sound knowledge of GMP.
Key Responsibilities:
·Responsible for the implementation of Data integrity plan in Quality Control laboratory.
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Responsible for the implementation of all relevant PQS in Quality Control Laboratory.
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Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required.
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To ensure that all SOP’s and test procedures which use in Quality Control lab are current and in use.
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EHS committee member, ensuring implementation of EHS measures/actions within QC laboratories.
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Maintains Reference standard supplies inventory required for FG analysis by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
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To ensure that any compendia changes, PQS revision and monograph related to QC laboratory activity incorporated and updated with current procedures.
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Ensure Quality control policies or procedures are appropriate, establish and/or revise, as necessary and ensure fully adherence with all applicable Laboratory procedures.
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Reviewing the required SOPs related to chemical laboratory tasks and ensuring that these procedures are strictly followed during laboratory practices.
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Training the analysts on the implementation of current new SOPs, Standard Test Procedures (STPs) and new techniques in the analysis. Document and approve the training documents.
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Managing all QC laboratory resources efficiently, responsible for all aspects of the laboratory including equipment, employees, supplies, software and documentation.
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Coaching and developing chemical laboratory colleagues to achieve high performance.
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Coaching QC colleagues with their improving projects and sponsoring their projects.
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Perform lab investigations and ensure all OOS and OOT results are timely initiated and notify to manager.
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Reviewing the Analytical Method Transfer Exercise (AMTE) results from local (new analysts, new test procedures) and from labs in other companies and/or countries and supporting them.
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Clearly communicate expectations and provide assistance in the development and implementation of quality initiatives via identifying the opportunities and support QC team in ZD/PHP Projects.
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Perform data trending and driving continuous improvement in laboratory process.
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CAPA against APRR recommendations, audits, inspections, events, LIR timely logged in commitment tracking module in gQTS and strictly adherence of committed time line.
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Timely Initiation and Completion of all action plan in change controls related to functional areas.
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Ensuring good relations and effective communications with all team members and
responding politely and in a timely fashion to internal and external customers by
following all Pfizer values.
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To perform any other assignment given by Manager QC and when required.
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