Quality Assurance Chemist Hetero Labs Limited

0.0 - 4.0 years

0 Lacs

Visakhapatnam, Andhra Pradesh, India

On-site

Key Responsibilities: Documentation and Compliance: Review batch manufacturing records (BMR) and batch packing records (BPR) for completeness and compliance with Good Manufacturing Practices (GMP). Prepare, review, and approve standard operating procedures (SOPs), work instructions, and specifications. Ensure compliance with pharmacopeial standards (USP, BP, IP, EP) and regulatory requirements (FDA, WHO, ICH, etc.). Batch Release: Evaluate and approve batch documentation for the release of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs). Ensure that all deviations, change controls, and out-of-specification (OOS) results are resolved prior to batch release. Audits and Inspections: Participate in internal audits, vendor audits, and regulatory inspections. Assist in preparing and implementing corrective and preventive actions (CAPA) based on audit findings. Maintain audit readiness and ensure compliance with all regulatory requirements. Change Control and Deviations: Manage change control processes for materials, processes, and equipment. Investigate deviations and non-conformances, identify root causes, and implement CAPAs to prevent recurrence. Validation and Qualification: Support validation activities, including process validation, cleaning validation, and analytical method validation. Ensure equipment and systems are qualified (IQ, OQ, PQ) as per protocols. Training and Awareness: Provide training to production, QC, and QA teams on GMP, quality systems, and SOPs. Promote a culture of quality and continuous improvement within the organization. Quality Systems Maintenance: Maintain and monitor quality systems such as deviation management, CAPA, and change control. Conduct periodic quality reviews and ensure timely updates of all quality-related documents. Stability Studies and Risk Management: Monitor stability studies for APIs and ensure compliance with ICH guidelines. Conduct risk assessments for processes, equipment, and materials. Qualifications and Skills: Education: Master's degree in chemistry or B. Pharmacy. Technical Skills: Strong knowledge of GMP, GLP, and regulatory guidelines. Familiarity with quality systems such as deviation management, CAPA, and document control. Understanding of process validation, equipment qualification, and analytical method validation. Soft Skills: Strong attention to detail and organizational skills. Effective communication and documentation abilities. Problem-solving mindset and ability to work collaboratively across departments. Work Environment: Office and manufacturing site-based role with occasional exposure to production environments. May require flexible hours to meet production or audit schedules. Key Performance Indicators (KPIs): Timeliness and accuracy of documentation review and approval. Compliance with GMP and regulatory requirements during audits and inspections. Effective resolution of deviations and implementation of CAPAs. Training effectiveness and adherence to SOPs by team members.

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