Executive / Sr. Executive - Quality Control

Key Responsibilities:

• Validation Protocol Development: Develop and implement validation protocols (IQ/OQ/PQ) for equipment, systems, processes, and methods in the QC laboratory.
• Execution of Validation Activities: Conduct validation studies, including risk assessments, to ensure compliance with regulatory requirements and company standards.
• Documentation: Prepare and review validation documents, including protocols, reports, standard operating procedures (SOPs), and work instructions.
• Compliance: Ensure all validation activities comply with GMP, FDA, EMA, and other relevant regulatory guidelines.
• Audit Support: Support internal and external audits by providing validation documentation and responding to audit findings related to QC validation.
• Continuous Improvement: Identify opportunities for continuous improvement in validation processes and implement best practices.
• Training: Train QC staff on validation procedures and ensure adherence to validation standards and practices.
• Cross-functional Collaboration: Work closely with QA, manufacturing, and R&D teams to ensure successful validation activities and integration of new products/processes into production.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Experience: Minimum of 3 years of experience in QC validation within the pharmaceutical industry.
• Knowledge: In-depth knowledge of validation principles, GMP, FDA, EMA regulations, and industry standards.
• Technical Skills: Proficiency in analytical techniques and instrumentation, such as HPLC, GC, spectroscopy, and microbiological methods.
• Documentation Skills: Strong experience in writing and reviewing technical documents.
• Attention to Detail: High level of accuracy and attention to detail.
• Problem-solving: Excellent analytical and problem-solving skills.
• Communication: Strong verbal and written communication skills.
• Teamwork: Ability to work effectively in a team environment and collaborate with cross-functional teams.

Preferred Qualifications:

• Certification in Quality Assurance or Validation from a recognized institution.
• Experience with statistical analysis and validation software.
• Familiarity with Lean Six Sigma methodologies.

Working Conditions:

• Primarily office-based with regular interaction in laboratory and manufacturing environments.
• May require occasional travel for audits, training, and conferences.