Quality Specialist
: Job Details :

Responsibilities:

• Provide quality assurance oversight for C&Q, verification, and validation activities, ensuring compliance with GMP, FDA, and other regulatory requirements.
• Collaborate with engineering, operations, and IT teams to ensure the implementation of quality standards in automated and computer-controlled systems.
• Ensure all quality activities are conducted following applicable policies, procedures, and regulatory expectations.
• Support regulatory inspections and audits, providing documentation and responses as required.
• Lead and provide oversight for commissioning, qualification, and validation of warehouse equipment and systems.
• Review and approve validation documentation, including URS, FRS, IQ, OQ, and PQ protocols.
• Ensure appropriate risk-based approaches are applied to validation and verification activities.
• Monitor and assess changes to computerized systems and automated processes to ensure continued compliance.
• Identify opportunities for quality improvements and implement corrective and preventive actions (CAPAs).
• Support the development and implementation of quality systems, including change control, deviations, and investigations.
• Provide input into process optimization initiatives to enhance operational efficiency while maintaining compliance.
• ct as a quality advocate, providing guidance to project teams, suppliers, and stakeholders on quality and compliance matters.
• Participate in cross-functional project meetings to ensure quality considerations are integrated into project deliverables.
• Provide training and mentorship to team members on quality expectations and regulatory requirements.

Requirements:

• Bachelor's degree in a scientific field (Engineering, Biology, Chemistry, or related disciplines) or equivalent experience.
• Strong knowledge of pharmaceutical quality systems and GMP regulations, with experience in manufacturing environments.
• Previous experience with C&Q, verification, and validation oversight, particularly in automation and computer systems validation (CSV).
• bility to work independently while collaborating with cross-functional teams to ensure compliance and quality objectives are met.
• Excellent documentation skills and attention to detail, with experience in writing and reviewing technical reports.
• Willingness to work 3 days per week on-site or 2 weeks on / 2 weeks off schedule.
• Experience with quality oversight in warehouse or logistics operations within pharmaceutical manufacturing.
• Knowledge of industry standards such as GAMP 5, 21 CFR Part 11, Annex 11, and relevant data integrity guidelines.
• Strong problem-solving and critical-thinking skills to address quality challenges proactively.
• Experience with electronic quality management systems (eQMS) and document control systems.