Quality Assurance and Change Control Specialist
About The Position
Quality Assurance Procedures & Change Control Coordinator
Key Responsibilities
- Responsible for managing the plant's procedures system, quality documentation, and ensuring accurate, compliant, and controlled documentation practices.
- Ensured continuous compliance with regulatory requirements and GMP standards throughout change implementation processes and documentation activities.
- Managed controlled documents and quality records within the organization.
- Oversaw the full lifecycle of Standard Operating Procedures (SOPs), including drafting, reviewing, updating, approval, distribution, and periodic revision.
- Maintained document control processes, ensuring that only current and approved versions of documents were available and used across departments.
- Implemented procedural and quality-related updates resulting from operational and regulatory changes.
- Monitored SOP expiration dates and initiated periodic reviews and re-approvals.
Change Control Management
- Managed, reviewed, and monitored change control requests related to equipment, processes, software systems, and raw materials, ensuring product quality and food safety compliance.
- Conducted risk assessments prior to change approvals in collaboration with cross-functional teams.
- Tracked change control milestones, action items, and implementation progress through closure.
- Verified effectiveness of implemented changes and approved change control closure upon completion of all required activities.
- Analyzed quality metrics and prepared management reports and performance indicators.
Training
- Delivered GMP, Quality Assurance, and SOP training programs to plant employees.
- Ensured employees received appropriate training on new and revised procedures before implementation.
Internal & External Audits
- Coordinated plant readiness for regulatory, certification, and customer audits, with emphasis on document control, SOP management, and change control systems.
- Supported auditors during inspections and provided responses within areas of responsibility.
- Monitored and followed up on corrective and preventive actions (CAPAs) resulting from audit findings.
Requirements
Qualifications & Requirements
Practical Engineering Diploma (Associate Degree) in Food Technology, Biology, Chemistry, or Industrial Engineering and Management.
Bachelor's degree in Chemical Engineering, Food Technology Engineering, Biology, Chemistry, or Industrial Engineering and Management – an advantage.
Experience and professional knowledge in a Quality Assurance department within an industrial/manufacturing environment, with preference given to candidates with hands-on experience in procedure management, document control, and change control implementation under regulatory requirements.
Strong organizational skills and attention to detail, with the ability to work accurately in accordance with procedures, standards, and regulatory requirements.
Excellent technical writing and documentation skills.
Ability to analyze processes and identify opportunities to reduce quality-related risks and non-conformities.
Strong interpersonal and communication skills.
Good command of English (written and verbal).
Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint, as well as experience working with Priority ERP.
