Job Title: Quality Assurance OfficerCompany: Valens Pharmachem Pvt. Ltd.Location: Nadiad, Gujarat, IndiaAbout Us:Valens Pharmachem Pvt. Ltd. is a leading pharmaceutical company committed to delivering high-quality active pharmaceutical ingredients (APIs) to meet global healthcare needs. With a focus on innovation, compliance, and excellence, we strive to ensure the highest standards of quality and safety in all our products.Job Description:We are seeking a highly motivated and experienced Quality Assurance Officer to join our team. The ideal candidate will have 2-3 years of relevant experience in the pharmaceutical API industry and possess a strong understanding of quality assurance principles and regulatory requirements.Responsibilities:1. Compliance Management: - Ensure compliance with regulatory standards, including but not limited to cGMP (current Good Manufacturing Practices), ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, and company policies. - Conduct internal audits to assess compliance levels and identify areas for improvement. - Support regulatory inspections and audits by external agencies, addressing findings and implementing corrective actions as necessary.2. Documentation and Record Keeping: - Maintain accurate and up-to-date documentation related to quality assurance activities, including batch records, SOPs (Standard Operating Procedures), and validation protocols/reports. - Review and approve documentation pertaining to manufacturing processes, analytical methods, and quality control testing.3. Quality Systems Management: - Participate in the development, implementation, and maintenance of quality management systems (QMS) to ensure continuous improvement and adherence to quality standards. - Monitor the effectiveness of quality systems through metrics, trend analysis, and performance indicators.4. Investigation and CAPA (Corrective and Preventive Actions): - Lead investigations into deviations, out-of-specification (OOS) results, complaints, and other quality incidents, identifying root causes and implementing appropriate corrective and preventive actions. - Collaborate with cross-functional teams to address quality issues promptly and effectively, minimizing potential risks to product quality and patient safety.5. Change Control and Risk Management: - Assess proposed changes to processes, equipment, or systems to determine potential impacts on product quality and regulatory compliance. - Conduct risk assessments and develop risk mitigation strategies to ensure the controlled implementation of changes.6. Training and Development: - Provide training on quality procedures, policies, and regulatory requirements to employees at all levels of the organization. - Foster a culture of quality and compliance by promoting awareness and understanding of quality principles and objectives.Qualifications:- Bachelor's / Master's degree in Pharmacy, Chemistry, or related field.- 2-3 years of experience in quality assurance roles within the pharmaceutical API industry.- Strong knowledge of cGMP regulations and international quality standards.- Excellent analytical, problem-solving, and decision-making skills.- Effective communication and interpersonal skills, with the ability to collaborate cross-functionally.- Strong command over English, both written and verbal, with the ability to communicate complex ideas clearly and concisely.- Proven ability to work collaboratively as part of a team, fostering a supportive and inclusive work environment.- Proficiency in Microsoft Word and other relevant software applications for documentation and data analysis.- Detail-oriented mindset with a commitment to accuracy and precision.- Ability to adapt to changing priorities and deadlines while maintaining a high level of productivity.- Familiarity with quality management software and tools is a plus.Join Us:If you possess the skills and experience outlined above and are eager to contribute to our mission of delivering high-quality pharmaceutical products, we encourage you to apply for this position through LinkedIn or send us an email at qa.head@valens.co.in
