Job Title: Quality Assurance Specialist
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team.
* Provide key support to the quality function within stability management, material management/supply chain, and quality assurance.
* Coordinate the stability program-management including study activations, creation and approval of stability studies, receipt and activation of stability samples, equipment monitoring, and stability unit trend reviews.
* Responsible for packaging/preparation of the product in the laboratory.
* Responsible for quality-related matters specific to area of responsibility, including any deviations and associated investigations.
* Generate certificates of analysis/conformance to support shipping requirements.
* QA review of batch records, cleaning tickets, and logbooks.
* Assist with reconciliation of laboratory notebooks as required.
* Carry out day-to-day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.
* Provide backup for specific QA assistant activities as required.
* Work effectively within the QA function to deliver on objectives.
Requirements:
* Level 8 degree in a relevant discipline (Hons BSc, MSc, Chemistry, Engineering, Quality, or other related discipline).
* 3 years' experience in the pharmaceutical and biopharmaceutical sector.
* A minimum of 2 years quality experience in a pharmaceutical environment.
* Ability to work on own initiative and to challenging schedules.
* Excellent interpersonal and communication skills.
* Experience managing third-party relationships desirable.
* Experience in document management.
* Experience with document management in the pharmaceutical sector.
* Excellent communication skills in English.
* System experience is an advantage: SAP, Veeva Vault, Trackwise, Darwin, SuccessFactors, MS Word, Excel, Teams.
Key Attributes:
1. Coordination – Positive Influence: Demonstrated ability to address issues as they arise and act in a positive collaborative manner. Faces up to issues quickly and directly acts when necessary or asks for help. Trusted within their team, with a demonstrated commitment to follow through on actions. Is interested in own performance and seeks feedback to improve.
2. Ability to Lead – Is seen as a team player and works collaboratively within team and across the business. Can motivate others and is someone people enjoy working with. Can proactively bring a group with them to get a task completed where needed.
3. Communication – Demonstrated effective communication skills both written and oral. Willing to speak up on topics in group situations or 1:1 in a positive and constructive way. Demonstrated credibility and positive influence through communication style within their team.
4. Relationship Builder – Approachable: is easy to approach and talk to, spends the extra effort to put others at ease, actively listens and builds rapport with team members. Is interested in, and cares about others in the team and understands people and their perspective and can use this insight to remain calm and work through situations objectively.
5. Business Knowledge – Relevant experience in the business and demonstrated performance in delivery. Shows interest in how the business works and looks for opportunities to learn. Looks at better, simpler ways and will take initiative and will run proactively with actions, improvements, and non-routine activities. Demonstrated self-management, prioritisation, and organisational skills.
6. Decision Making – Demonstrated ability to raise issues with the team and management if there is a potential for a problem in the process. Assist others in the decision-making process.
7. Learning agility and Curiosity – Learns quickly and is proactive in obtaining new knowledge and skills. Open to different experiences/perspectives including learning new technologies and consistently getting involved in troubleshooting.
8. Flexibility – Demonstrated ability to be flexible in working arrangements depending on business needs.