Production Chemist

The Approved Chemist in the Production Department is responsible for overseeing and ensuring the quality and safety of pharmaceutical products during the manufacturing process. Your role involves monitoring production activities, conducting in-process quality checks, and ensuring compliance with regulatory standards, Good Manufacturing Practices (GMP), and Standard Operating Procedures (SOPs. You will collaborate closely with cross-functional teams, including quality assurance, engineering, and regulatory affairs, to uphold the highest standards of product quality. Key Responsibilities: In-Process Monitoring: - Monitor and evaluate the manufacturing process to ensure product quality and adherence to established standards. - Conduct in-process tests and analyze samples for chemical, physical, and microbiological attributes during production. - Ensure compliance with batch production records and all processes meet GMP and FDA standards. Batch Processing: - Supervise batch manufacturing and ensure adherence to SOPs. - Review and approve raw materials and finished product batches in collaboration with the Quality Assurance team. - Validate equipment and processes to ensure production consistency. Documentation and Record Keeping: - Maintain accurate and detailed records of production processes, tests, deviations, and outcomes. - Ensure proper completion and filing of reports, including batch production records and change control documentation. Compliance and Safety: - Ensure manufacturing processes comply with pharmaceutical regulations and company policies. - Adhere to safety protocols and participate in safety audits. - Provide GMP and chemical handling procedures training to production staff. Problem Solving & Troubleshooting: - Investigate and resolve deviations, non-conformance issues, or process failures. - Identify root causes of production discrepancies and implement corrective and preventive actions. Collaboration: - Collaborate with quality assurance, quality control, and R&D teams for continuous production improvement. - Work with the engineering team to maintain manufacturing equipment. Qualifications: Education: - Bachelors or Masters degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field. Experience: - Minimum 1-3 years of experience in pharmaceutical manufacturing or a related industry. - Strong knowledge of GMP, regulatory requirements, and pharmaceutical production processes. - Experience in solid dose, sterile, or liquid formulations is advantageous. Skills: - Proficiency in chemical analysis techniques and laboratory equipment. - Strong understanding of pharmaceutical manufacturing processes. - Excellent analytical and problem-solving skills. - Ability to work in a fast-paced environment with strong attention to detail. Certifications: - Approval certificate from drug officer or name in approved list issued by the drug office. - Certification in GMP, pharmaceutical production, or related quality control processes is beneficial. Working Conditions: - Night shifts required with flexibility in working hours. - Work performed in a manufacturing environment with occasional lab-based tasks. - Adherence to safety standards is mandatory. Physical Requirements: - Ability to stand or move for extended periods during night shifts. - Ability to handle and operate laboratory and production equipment.,