Quality Assurance Specialist Senior Technical QA

Purpose : The company is expanding its manufacturing capabilities with a state-of-the-art Aseptic Manufacturing Facility, and we're looking for a highly experienced Senior QA Specialist to join our team. This is a unique opportunity to play a key role in a high-impact project, providing Quality Oversight across Facility, Equipment, Utility, and Process Design, Installation, and Qualification. This role requires a strong focus on QA leadership in the design, installation, and qualification of facility, equipment, utility, and process systems, with particular emphasis on Validation Oversight. Responsibilities : Provide QA leadership during facility design, and layout Provide overall quality direction for processes and procedures associated with project Lead QA review and approval of URS, DS, QRAEs, and IQ / OQ / PQ protocols and reports. Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards. Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards. Ensure validation documentation is robust, traceable, and inspection-ready. Drive risk assessments and mitigation strategies for new equipment and processes. Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations. Ensure all activities align with Company safety standards, SOPs, and regulatory expectations. Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations. Requirements University degree in a Science or Engineering-related discipline. Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry. Proven expertise in facility startup and Quality Oversight of Validation activities. Experience with change control, non-conformance resolution, and CAPA implementation. Excellent organiza tional, communication, and collaboration skills. Ability to work independently with minimal supervision and operate effectively across functional boundaries. Critical thinking and problem-solving abilities. Additional Skills : Familiarity with Quality by Design (QbD) Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus. Team-oriented mindset with the ability to thrive in a collaborative decision-making culture . Skills : Facility Startup CAPA implementation QA leadership QA review