Quality Assurance Manager

As a QA Chemist at Sinterx Pharma Private Limited, you will play a crucial role in ensuring that all API intermediate manufacturing operations adhere to established quality standards, GMP requirements, and regulatory guidelines. Your responsibilities will include: - Reviewing and approving GMP documentation such as BMRs, BPRs, SOPs - Overseeing batch records, managing deviations, and CAPA - Conducting internal audits and ensuring compliance throughout the production lifecycle Qualifications required for this role include: - Bachelor's or Master's Degree in Chemistry, Pharmaceutical Sciences, or Life Sciences - 5 to 8 years of experience in Quality Assurance within the API or API Intermediate manufacturing industry - Hands-on experience in preparing and reviewing GMP documentation - Strong understanding of regulatory guidelines (GMP, ICH, FDA, etc.) and data integrity practices In this role, you will need to: - Review and approve batch manufacturing records, change controls, deviations, and CAPAs - Ensure compliance with cGMP, ICH, FDA, and other regulatory guidelines - Perform in-process quality checks and review raw material and intermediate usage You will also be responsible for: - Managing documentation systems including SOPs, validation protocols, and logbooks - Supporting internal audits, vendor audits, and regulatory inspections - Collaborating with cross-functional teams to maintain quality excellence and support regulatory inspections Key skills required for this role: - Strong knowledge of GMP regulations, ICH guidelines, and data integrity practices - Proficiency in reviewing and managing GMP documentation - Strong analytical, problem-solving, and decision-making abilities - Experience in handling deviations, CAPA, and risk assessments Key attributes we are looking for in a candidate: - High attention to detail and commitment to compliance - Strong communication and interpersonal skills - Ability to multitask and manage priorities effectively - Proactive approach to continuous improvement and regulatory readiness If you are interested in this opportunity, please share your profile at Hr@sinterxpharma.co.,