Technical Specialist Validation QA

Accountability:

The role’s primary accountability is to ensure that all validation activities are executed with scientific rigor and in full compliance with regulatory and company standards, thereby supporting robust pharmaceutical manufacturing and ensuring patient safety.

Essential Job Function:

Create, manage, and oversee the generation of technical documents in support of Pharmaceutical Development, Manufacturing Operations, Facilities, Quality Assurance and Quality Control. Technical documents may include Standard Operating Procedures, CAPAs, OOS, Equipment Qualification, Process and Cleaning Validation protocols and reports for the Pharmaceutical Services Division of GAT.

Qualifications and Skills:

• BA/BS degree or certificate in a technology related field (Biology, Chemistry, Pharmacy, Engineering, etc.)
• Must have at least 5 years of development or manufacturing experience in a cGMP solid dosage manufacturing environment with the ability to understand the fundamental processing stages required to independently create the protocols, change controls, investigations, deviations, and final reports required to conduct equipment qualification, process validation, and cleaning validation activities.
• Should possess a pharmaceutical manufacturing/development and cGMP background in a solid dosage form environment with preferred background in fluid bed processing.
• Must be able to demonstrate an understanding of compliance and write well-defined processing steps/instructions, with a logical process flow and an emphasis on Quality processing. Must have the ability to articulate their point clearly and concisely through the power of the written word.
• Strong computer skills and proficiency in Microsoft Office suite are a necessity, with an ability to accurately convey information in both verbal and written form. Strong command of the English language is essential.
• Must be detail oriented and able to meet deadlines. Solid organizational skills are a necessity, with a demonstrated ability to organize and track several projects simultaneously. The ability to follow-up with multiple departments is required.

Responsibilities:

• Interacts with and coordinates with representatives of technical associates, project leads, customers and subject matter experts from other departments (internally and externally) to create Process, Cleaning and Computer Validation Protocols/Reports, IQ/OQ/PQ documents, facility commissioning documents, investigations, CAPAs, change controls, product development reports, scale up documents, etc. with a strong emphasis on the following pharmaceutical processes: fluid bed granulation, blending, milling, compression, encapsulation, coating & packaging.
• Maintains, updates, and utilizes document templates, guidelines, and other procedures to remain consistent across processes and individual customers to assure a consistent level of cGMP standards for GAT’s protocols, and all IQ/OQ/PQ templates that are in alignment with GAT approved master plans.
• Supports internal compliance audits of various departments (collects relevant data for evaluation, examination of documents and records, interview with employees, tour and/or observation of work in progress, analyzes the information collected and determines the compliance status of the audited area to that of the required performance standards).
• Supports the department Head for all process, cleaning and computer equipment validation activities for the site.
• Prepares and/or updates divisional/ departmental SOPs where applicable, initiating change request and the preparation of any forms or attachments that may accompany the SOP.
• Researches and understands new equipment through user manuals to create IQ/OQ/PQ documents for equipment qualification program.
• Creates and executes cleaning validation/ verification protocols and produces follow-up reports. Maintains accurate documentation for the cleaning validation program at GAT. Coordinates with the Planning department and routinely reviews the manufacturing schedule to inform the cleaning validation/ verification activities.
• Creates equipment, facilities, and systems commissioning and qualification protocols and reports.
• Other tasks as assigned by Management.