QA Validation Specialist

What you need to know:
You will support new Validation and Commissioning programs across site as well as the periodic review of validated systems within the Drug Substance, Facilities, and laboratories to ensure ongoing compliance to cGLP and cGMP.
Your New Job:
This role will be key in supporting the day to day running of the Validation dept, Laboratories and Projects to ensure that processes are streamlined, and business objectives adhered to. You will be the key in driving QA compliance to ensure standards are best in class across our industry, a benchmark for others to aspire to. You will support the specialist role function in each area. Bring energy, knowledge, innovation to carry out the following: Work as directed by the Quality Assurance Validation lead according to company safety policies, cGMP and cGLP.

Key Duties and Responsibilities:

• Collaborate with project-based teams, Validation, Microbiology, IT, Engineering utilities and other departments to provide QA support for commissioning, decommissioning and Validation project across site.
• Responsible for the approval of Validation Lifecycle documents and reports supporting the introduction of new laboratory and process equipment.
• Responsible for the approval of Validation Lifecycle documents and reports supporting Temperature mapping, EMPQ and AVS studies
• Provide Quality oversight of Periodic review and Equipment revalidation.
• Provide real time review of commissioning test scripts and escalate issues in a timely manner to CQV and QA leadership as appropriate.
• Support the Site Calibration program
• Act as Quality Assurance point of contact for Cleaning Validation, WFI PQ, and PQ of process equipment including Filter Integrity, parts washers, Autoclaves and process Validation studies, etc
• Act as a Champion for developing a Data Integrity Culture across site.
• Working Knowledge of GMP regulatory guidelines with the ability to accurately interpret, and provide quality guidance for validation activities in the drug substance and laboratory areas
• Any other tasks as directed by QA Validation Lead.

What are we looking for?

• BSc Degree in relevant Science. MSc preferable.
• Minimum 1 year Validation / CQV experience.
• Experience and expertise that add value to the business; Chemistry, Chemical Eng, Biological science, Biotechnology in a Biopharmaceutical GMP setting.
• Knowledge of cGMP Process & utility Quality Systems.
• Knowledge of Deviation management, Change Management, Risk Management.
• KNEAT, Cleaning Validation, Environmental Monitoring, Filter Validation studies and Single use equipment as distinct advantage.
• Knowledge of regulatory guidelines supporting Drug substance manufacturing: ICH, EU and FDA.
• Strong technical writing skills required.
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globally.

​​​​​​​Apply for this job now or get in touch with Brenda on 087-4343544

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