Sr Quality Assurance Analyst

Job Description

KEY/ACCOUNTABILITIES: Weight %

This is a list of Core Duties and must not be taken as a definitive list. You may be asked from time to time to undertake other duties, either in or out of your area of responsibility

1) People 25%

Maintain a strong relationship with management and colleagues in the business units, support functions and quality site and global functions. Articulate the necessary quality requirements in a clear concise and persuasive manner.

2) Strategic 25%

To work with the Senior Manager and Associate Director on the delivery of the company quality plan and global regulatory requirements for the site

• Assess quality implications of new regulatory guidance and implement necessary changes for area of responsibility. Manage Quality requirements for process changes and new product introductions as deemed necessary
• Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
• Represent the company in Ministries of Health inspections as deemed necessa

3) Management 25%

Provide Quality input as required, providing direction on the day to day activities as a member of the site quality team

• Foster an environment of continuous improvements for the compliance areas by identifying and implementing efficiencies and quality improvements
• Support Process changes where compliance services are required compliance services are required
• Work with BU representatives and support functions to ensure that global site metrics are achieved and exceed each month through the implementation of department process improvements and working with key site vendors

KEY REQUIREMENTS

Education and Experience/Knowledge:

1. Proven track record in a quality discipline in the Pharma/Medical Device environment.
2. Third level Science qualification
3. Clear understanding of working within a regulated environment
4. Excellent communication skills
5. Ability to use sound judgment to make effective decisions within appropriate timeframes
6. Proven to be self-directed, self-motivated and ability to prioritise competing priorities Behaviours/Value:
7. Relationship Building : establishing excellent working relationships with all functions within the business unit and QA management team.
8. Communication: excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
9. Planning & Organising : excellent analytical skills. Ability to plan and schedule.
10. Decision Making : identify and understand issues, problems and opportunities whilst providing a viable solution.
11. Adaptability ; Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
12. Passion for results: - Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
13. Receptivity to feedback - Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.
14. Allergan Culture fit: Have a people centred approach to their management style whilst upholding the values and ethos of Allergan Other requirement (i.e travel)

Undertake any training or travel that the role may require, including the completion of quality inspections of third party contract facilities as required