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Quality Assurance Associate


Quarry Bay, CA 93402
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Job Details

**TITLE : Associate - Quality Assurance**

**DEPARTMENT : Supply Chain and Market Quality Operations**

**REPORTS TO : Quality Assurance Manager**

**UPDATED : 22 Nov 2017**


**Supply Chain and Market Quality Operations (SCM QO)**


**1. Resolution of Affiliate Quality Operation Issues**

Deviation Management (in conjunction with the PGS Quality Operations):

+ Investigates, together with appropriate local functions, deviations from Affiliate Quality Operation requirements that occur within the responsibility of the country organization and agrees and tracks preventive/corrective actions. Local investigations may relate to issues with contract manufacturers or logistics service providers etc and investigation input may be required for product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or

Product Complaint handling:

+ Manage the intake of complaints from the local market, triages by assigning class and criticality to the product complaint and forwards them to the appropriate investigating PGS /Contractor Site via the global complaints management system

+ Tracks complaint responses

+ Develops and issues responses to complainants in a timely manner

Notification to Management

+ Informs Affiliate Quality Manager and Regional Lead of significant deviations and complaints

+ Where required, attend Area Quality Review Teams (AQRT) meetings, as principal PCO representative, to provide the local perspective on the issue at hand. Provides AQRT Executive Summary for issues originating under the responsibility of the PCO

+ Ensures the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions

**2. SCM Quality Operation System**

+ Ensures timely implementation of all applicable Product Quality SOPs (issued by AQO) within the PCO.

+ Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs

+ Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.

+ Conducts internal assessments to assess compliance with product quality systems & processes, and to identify improvement opportunities.

+ Assess new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required

**3. Local Product Disposition**

+ Where required, performs local disposition of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.

+ Defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center

**4. Inspections and Internal Audit**

+ Leads preparation and coordination of Regulatory Agency and internal Pfizer inspections of SCM Quality Operation (GMP/GDP) activities at the PCO.

+ Works with local functions to define an appropriate action plan to address the inspection/audit observation

+ Tracks the implementation of the identified actions within agreed timeframes

**5. Local Contractor Quality Oversight**

+ Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors involved in manufacture, repackaging, laboratory testing or activities at Logistics Service Providers

+ Oversees quality operations at contractors, which includes but is not limited to:

+ Contractor Assessment and Approval : ensures all GMP/GDP contractors have been formally assessed and approved

+ Deviation Management: evaluates the impact of all significant deviations affecting Safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agrees corrective actions. If necessary, initiates the "Notification to Management" process

+ Quality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting (BRM), where existing

+ Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance

+ Facilitates the Pfizer Manufacturing Supplier Quality Assessment (MSQA) audit process at the contractor. Helps to define appropriate action plans for improvement and follow-up and communicate action closures.

**6. Quarantine Alert Notices (where non-Pfizer warehouses are used to receive and store product in the country)**

+ Receives and manages Quarantine Alert Notices (QAN) received from Primary Logistic locations

+ Establishes with LSP if product lots remain at the site and, if so, alerts the LSP to place the product on hold.

+ Informs the Primary Logistic Location and PGS Site/COQA of quantity of product still within Pfizer control and follows further instructions regarding product disposition.

**7. Oversight of local Repackaging and Relabeling Operations**

+ Ensures relabeler / repackager has been assessed and approved

+ Obtains regulatory approval of the repackaging/relabeling activity, if required under the local regulations

+ Informs the releasing site of the repackaging/relabeling activity

+ Reviews documentation related to the repackaging/relabeling operation

+ Releases the repackaged/relabeled product

**8. Development and Maintenance of Consistent Quality Culture**

+ Collects data and metrics on PCO quality performance and communicates this to PCO Management. This may involve a regular Management Quality Review process.

+ Provides ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture

+ Is an exemplar of the Quality Culture within the PCO


+ Report to Quality Assurance Manager


+ Degree in Medical /Sciences/ Engineering e.g. Pharmacy, Life Sciences, Pharmacology, Medical Engineering or related field

+ Enthusiasm in acquiring good medical and scientific knowledge for the defined therapeutic area(s)

+ Passion to gain a good understanding about the International and local pharmaceutical business and marketing practices

+ A strong desire to get a good understanding of the local medical and regulatory environment

+ 1- 5 year experience in pharmaceutical industry is preferred

+ Proficiency in English and good computer usage


Technical competencies


+ SOP Training and Compliance

+ Project and process management

+ Presentation/influencing skills

**Details/Comments (specific skills-expanded definition)**

+ Knowledge and demonstrated success in training and implementation. Maintain knowledge and expertise on all relevant SOPs

+ Demonstrate ability to manage complex projects and cross-functional processes required. Proactive planning and result orientated.

+ Demonstrate skills in delivering complex information; experience in presenting to small or large groups. Good interpersonal communication skills.

**Behavioral Competency**


+ Understanding stakeholder needs

+ Bigger pictures/ strategic perspective

+ Innovation

+ Influencing

+ Networking and alliance building

+ Sustain performance

**Details/Comments (Specific skills-expanded definition)**

+ Consider stakeholders, including Marketing colleagues, health professional, patients, in developing strategies and future directions.

+ Develop organizational vision within the global context and understanding of the business needs and information needs.

+ Utilize and encourage innovative approaches to build and maintain a competitive advantage.

+ Manage changes and acts as a champion of change across the company; uses facts, logic and personal credibility to influence the successful implementation of different process improvements.

+ Build a wide network and alliance, and utilizes stakeholder input to develop strategic thinking, distribute information and find opportunities for collaboration with external health professionals and Marketing colleagues

+ Hold oneself accountable for performance and encourage others to achieve and be accountable for performance.

+ Demonstrate strong and continuous learning capability and adaptability.

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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