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As Senior QA Validation and Qualification Expert, you will ensure and demonstrate that the specifications, the commissioning, the installation, the operational and performance qualification of new and modified production facilities, utilities and equipment, and the process performance qualification are designed and implemented, to produce a product that repeatedly and reproducibly meets critical attributes. You will also serve as the point of contact for the junior associates on the team as a mentor and trainer.
In addition, you'll manage key project temporary staff on the team to ensure adherence to project milestones and business needs.
In details, this includes the following responsibilities:
- Provide lead QA support for the qualification activities for equipment, utilities and facilities including approval of the qualification protocols and reports and other documentation
- Provide lead QA important support for the validation (process and cleaning) activities, including approval of the validation protocols and reports and other documentation
- Based on a deep knowledge of regulatory requirements such as EU GMP, FDA and internal requirements, ensure and demonstrate that equipment, utilities and facilities are able to meet critical attributes and that qualification and validation activities meeting current regulatory and internal GSK requirements
- Apply and develop a risk based approach as defined in ICH Q9 Guidelines, ISPE recommendations and internal requirements, focusing on the identification and assessment of risk to product quality
- Ensure that the qualifications and validations are in compliance with regulatory requirements and expectations in consideration of the current operating environment and existing industry trends
- Ensure that acceptable ranges are defined for critical parameters
- Assist and train the System Owners for ensuring their accountability to qualify / validate, and to document the systems under their responsibility
- Perform vendor assessment in order to define their capability of fulfilling Internal Requirements and minimize risk exposure
- Represent the QA qualification & engineering team at the site change control review committee and ensure that Change, Deviation and CAPA’s records are in full compliance with internal requirements and regulatory guidelines
Why You?Basic qualifications:
As Senior QA Validation and Qualification Expert, you show strong communication, organizational and interpersonal skills.
Furthermore, you display the following qualifications and competencies:
- Bachelor in Sciences (Engineering or Life Sciences)
- Minimum of 5 years in the pharmaceutical industry or equivalent
- Strong experience in in Commissioning and Qualification of Equipment and/or Facility and/or Utility, and in process and cleaning validation
We are looking for strong experience and/or skills in process validation
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.