Quality Assurance Associate

About the Role

We are seeking a Quality Assurance Associate who will play a vital role in supporting various quality management system activities, including milestone completion for projects, Annual Product Reviews, management of deviations, CAPAs, change control, SOP management, and overall quality assurance for the manufacturing, packaging, and release of commercial products at Apollo Health and Beauty Care.

Responsibilities

• Complete Annual Product Review (APR) reports on schedule by gathering information from batch records, investigations, product changes, and complaints.
• Collaborate with business units to review and manage Change Control Requests, ensuring compliance with Good Documentation Practices (GDP) and change management procedures.
• Assist in monitoring internal quality management system compliance by performing internal audits across production, facilities, validation, and laboratory areas.
• Identify continuous improvement opportunities within the QMS in partnership with quality colleagues.
• Serve as a Subject Matter Expert for investigations and quality risk management processes.
• Review and track deviation and investigation records, enforcing adherence to GDP and deviation procedures, including reporting and trending activities.
• Evaluate CAPAs, including tracking progress, follow-ups, reporting, trending, and assessing their effectiveness.
• Guide timely completion of deviations, CAPA, corrective work orders, change controls, and investigations across departments.
• Support the Compliance Specialist in reviewing batch records for product release.
• Create and maintain Quality Assurance and QMS standard operating procedures (SOPs).
• Manage controlled documents and system changes, conducting detailed impact analyses to confirm all necessary Good Manufacturing Practice (GMP) and qualification tasks are included and completed.
• Work closely with cross-functional teams such as Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs on quality-related matters.
• Participate in cross-training with fellow QA Associates.
• Manage logbook issuance, control, review, and archiving of controlled documents.
• Perform other assigned tasks as necessary.

Requirements

• At least 5 years of experience in GMP environments within biopharmaceutical or pharmaceutical manufacturing.
• Bachelor's degree or diploma in Chemistry, Biology, Engineering, or related disciplines.
• In-depth knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), international regulatory standards, and GMP operations.
• Ability to prioritize workload effectively and meet demands of internal and external customers in a dynamic, fast-paced setting.
• Experience supporting quality projects, with a focus on data analysis and evaluating contributing factors.

Additional Information

Apollo Health & Beauty Care Ltd. is committed to providing accommodations for candidates with disabilities throughout the recruitment process upon request. The outlined job description offers a general overview of responsibilities, which may be subject to change based on management's discretion. Only candidates meeting minimum qualifications will be contacted.

Benefits

• Access to gym facilities
• Dental insurance coverage
• Health insurance plan