About the Company
The QA Validation Specialist will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation.
About the Role
The QA Validation Specialist will be responsible for ensuring compliance with quality standards and regulatory requirements in a pharmaceutical manufacturing environment.
Responsibilities
- Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
- Document validation activities and results and maintain records for all validation activities.
- Analyse validation test data to determine whether systems or processes have met validation criteria.
- Author of validation reports.
- Develop and maintain validation master plan.
- Develops re-qualification or re-validation plans to keep the systems in validated states.
- Support audits and inspections as a subject matter expert.
- Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
- Work closely with stakeholders to coordinate validation activities.
- Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
- Train staff on validation procedures and maintain documentations for audits.
- Maintain knowledge of current regulatory intelligence and industry trends.
Qualifications
- Bachelor's degree in Engineering, Pharmacy, Science or a related field.
- Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
- Proficient with validation software tools.
- Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
- Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
- Strong sense of accountability and ownership of responsibilities.
- Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
- A commitment to maintaining high standards of quality, safety, and compliance at all times.
Required Skills
- Validation software proficiency.
- Analytical and problem-solving skills.
- Strong communication skills.
Preferred Skills
- Experience in the pharmaceutical or medical device industry.
- Familiarity with regulatory inspections.
Pay range and compensation package
Competitive salary and benefits package.
