Quality Control Manager at Spurt!

Responsibilities

• Assist and collaborate with the Quality Control Manager in all matters.
• Comprehend SOPs, forms, operational GMP training, and quality activities.
• Provide analytical support to the QC team.
• Track and trend data to proactively avoid non-conformances.
• Respond to alerts and action levels as necessary and resolve issues.
• Maintain the system for document storage and retrieval and train other employees on efficient system usage.
• Track and ensure effective delivery of products. Check on quality, expiry dates and product authenticity
• Manage the SOP periodic review programme, including managing the creation of new procedures or the obsolescence of retired procedures.
• Initiate and assist in preparing information and/or reports due to nonconformance, such as out-of-specification (analytical), deviations, and incident reports.
• Initiate, track, and follow up on Corrective Action and Preventive Action (CAPA).
• Confirm that all customer complaints are documented correctly and accurately and assigned to the appropriate department for review or investigation.
• Provide support for the company’s Material Review Board (Risk Assessment Programme) and the company’s internal audit programme.
• Initiate a formal improvement request when a deviation from the system occurs, possible improvements are identified, or nonconformity is identified, and ensure its closure.
• Perform and complete all standard weekly, monthly, and quarterly quality reports.

Experience/Qualifications

• BS/BA Preferred (Degree in chemistry, biology or similar area of expertise)
• A minimum of 3 years experience in pharmaceutical Quality Assurance, Quality Control or Regulatory (or Compliance) experience preferred
• Detailed knowledge of Quality Management Systems
• Relevant degree in pharmacy, chemistry, biology, or a related discipline.
• Proven experience in quality control, pharmaceutical manufacturing, or regulatory compliance.
• Strong knowledge of legal and administrative provisions, rules, and directives.
• Excellent verbal, interpersonal, and written communication skills.
• Ability to work independently and follow up on action items.
• Strong attention to detail and problem-solving skills.
• Ability to work in a fast-paced environment and manage multiple priorities.

Desired Traits

• Discrete and trustworthy, as you will often be a party to confidential information.
• Demonstrate ownership of all areas of work with a results-driven attitude, i.e., multi-task, meet deadlines, identify goals and priorities, and complete complex assignments with minimal direction.
• Knowledgeable about compound pharmacy practices.
• Must be able to work in a cleanroom space and be gown qualified
• Proactive, results-oriented with a strong attention to detail
• Experienced in writing executive summary reports, reviewing technical documents and interpreting statistical data analysis
• Strong organisational and time management skills
• Ability to analyse details and perform structured decision-making
• Good computer skills with knowledge of SharePoint
• Must be able to work independently