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QA Support Lead


Newbridge, NY 13684
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Job Details

The **QA Support Lead** acts as a role model, coach and mentor for other colleagues both within the QA team and other team's onsite to advance the 'Culture of Quality'. The role is self-directed and has responsibilities with respect to providing direction, coordinating, facilitating and undertaking activities pertaining to quality and compliance. The role provides technical expertise with a focus on continuous improvement and right first time. The role also represents the QA unit by liaising with internal and external customers or serving as a designee for QA Lead. This role may also act in a system specialist capacity, with responsibility for a specific GMP system.

**QA Support Lead** supports the QA Team and Partners with process teams and relevant departments to ensure that key quality systems are operated and maintained in a compliant manner and meet business needs.

Assist and participate in the assurance of QA compliance activities required to ensure that procedures are in accordance with cGMP and corporate policies, standards and values. Ensure continuous communication with relevant departments/functions to facilitate the implementation of plant wide initiatives. Liaising with external bodies (corporate, regulatory agencies, customers, CMOs) as required for the operation of Quality Systems / issue resolution

**General Responsibilities**

+ Ensure strict adherence to site policies/procedures, cGMP/GLP and environmental, health and safety regulations.

+ Ensure area of responsibility is maintained in a constant state of compliance and audit readiness in line with current regulations, PQS, and business needs.

+ All related procedures and documentation are maintained accordingly.

+ Safety and housekeeping considerations

+ Execute responsibilities in line with Right First Time principles Ensure resolution of and/or appropriate escalation of issues Demonstrating company values and Pfizer competencies

+ Ensure that all department metrics are adhered to

+ Provide subject matter expertise and support for systems, technologies and products.

+ Identify Continuous Improvement opportunities and Network best practices, and progress Continuous Improvement projects.

+ Participate in decision making in consultation with relevant stakeholders

+ Coaching and development of colleagues & process teams to enhance technical capability and Quality Culture Support the introduction of new products.

**Specific areas of responsibility**

Job specific accountabilities will be as per one or a number of the following dependent on role assignment within the department

**Supporting Activities**

+ Responsible for review and approval of responses to internal and external audits and regulatory reviews. Responsible for direct interaction with external auditors when required

+ Review and approval of procedures, reports, metrics related to quality systems, ensuring inter-system links are maintained and hand-offs are managed.

+ Lead / Participate in forums required to support the operation of Quality Systems / Process

+ Act as system owner for the relevant computer systems used in the management / execution of areas of responsibility.

+ Conduct internal audits

**Quality Systems**

+ Inspection readiness / preparation and Management.

+ Ensure effective operation of Quality Systems / business functions within their assigned area of responsibility and undertake specific roles within these systems as process / procedure requires.

**Operations Support**

+ QA oversight for new product introduction and area commercialization including Qualification and Validation.

+ Liaising with internal and external stakeholders to lead/deliver requirements for Quality related elements (e.g. agreements, investigations, risk assessments, document approval, change control, CAPA) in line with SOPs and relevant Quality Agreements.

+ Batch Review and Release (where licensed QP)

+ Regulatory Support for products/projects (e.g. GMP requirements, Marketing Authorization Compliance)

**Organization: People, Leadership, Internal Communications**

+ Accountable as a leader in the Quality organization

+ Accountable for ensuring effective employee engagement is maintained within the organization. Responsible for ensuring that routine communication meetings are held and ensuring that effective communication is maintained.

+ Responsible for ensuring compliance with EHS policies and procedures relevant to their area

+ People Management responsibilities may be required depending on specific assignment

**Culture of Quality & Compliance**

+ Accountable for embedding a culture of Quality and Compliance within their organization (including EHS & Financial compliance).

+ Responsible for ensuring appropriate accountability is delegated to key personnel and for implementing appropriate quality risk management tools / decision making.

+ Promoting Quality and Compliance expectations and culture across the organization.

**Customer Responsiveness**

+ Ensure appropriate management structures and inter-function communications are in place to maintain optimized business performance. Establish appropriate structures / inter function /CMO communications and partnerships to ensure optimized customer service, including training / mentoring of system users.

**Directs and Facilitates the Reporting Process**

+ Directs and facilitates the reporting process to measure the output and report the departmental performance metrics and quality issues to plant management (metrics / KPIs).

+ Provide oversight and escalation for site performance on QA/Compliance metrics.

+ Ensure PRR sub-element reports are generated on time and in full.

+ Ensure trend reports and system reviews are conducted and communicated where required (escalation / standing meetings & committees e.g. Site Quality Review Team)


+ Third level Qualification/degree in a life science/relevant technical discipline.

+ Exceptions may be considered where relevant experience and correct attitude and behaviour exist (this may be supplemented by further education in parallel).

+ QP Eligible desirable


+ Minimum of 5 years' experience in the pharmaceutical industry in the area of Quality Assurance (exceptions may be considered).

+ Experience in dealing with Regulatory compliance desired.

+ Ability to represent the company in external forums

Closing date for applications is Monday 12th March 2018

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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