Assistant Manager - Quality Control Validation

As an Assistant Manager - Quality Control Validation at SAVA Healthcare, you play a crucial role in ensuring the quality and compliance of manufacturing processes and products through validation protocols. Your responsibilities include: - **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**: - Bachelors or Masters degree in Chemistry, Pharmaceutical Sciences, or a related field. - **Experience**: - Minimum of 5 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. In addition, you may possess: - **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. Please note that the job is primarily office-based with regular interaction in laboratory and manufacturing environments. Occasional travel may be required for audits, training, and conferences. Thank you for considering a career with SAVA Healthcare.,