Approved Chemist

The Approved Chemist in the Production Department will be responsible for overseeing and ensuring the quality and safety of pharmaceutical products during the manufacturing process. This role involves monitoring production activities, performing in-process quality checks, and ensuring compliance with regulatory standards, Good Manufacturing Practices (GMP), and Standard Operating Procedures (SOPs). The chemist will work closely with cross-functional teams, including quality assurance, engineering, and regulatory affairs, to ensure 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 ensure all processes meet GMP and FDA (or relevant authority) standards.
- **Batch Processing**:

- Supervise batch manufacturing and ensure that each step of the process is followed as per SOPs.
- Review and approve raw materials and finished product batches in collaboration with the Quality Assurance team.
- Validate equipment and processes to ensure consistency in production output.
- **Documentation and Record Keeping**:

- Maintain and verify accurate and detailed records of production processes, tests, deviations, and outcomes.
- Ensure that all reports, including batch production records and change control documentation, are completed and filed properly.
- **Compliance and Safety**:

- Ensure that the manufacturing processes comply with pharmaceutical regulations (FDA, EMA, etc.) and company policies.
- Adhere to safety protocols and participate in safety audits.
- Provide training to production staff on GMP and chemical handling procedures.
- **Problem Solving & Troubleshooting**:

- Investigate and resolve any deviations, non-conformance issues, or process failures.
- Identify root causes of any production discrepancies and implement corrective and preventive actions (CAPA).
- **Collaboration**:

- Collaborate with quality assurance, quality control, and R&D teams to ensure continuous improvement in production.
- Work with the engineering team to ensure proper calibration and maintenance of manufacturing equipment.

**Qualifications**:

- **Education**:

- Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field.
- **Experience**:

- Minimum 1-3 years of experience in pharmaceutical manufacturing or a related industry.
- Strong knowledge of GMP, regulatory requirements, and production processes for pharmaceuticals.
- Experience in working with solid dose, sterile, or liquid formulations is an advantage.
- **Skills**:

- Proficiency in chemical analysis techniques and laboratory equipment.
- Strong understanding of pharmaceutical manufacturing processes (e.g., mixing, granulation, drying, tablet compression, coating).
- Excellent analytical and problem-solving skills.
- Ability to work in a fast-paced environment and handle multiple tasks efficiently.
- Strong attention to detail and commitment to maintaining the highest quality standards.
- **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 a plus.

**Working Conditions**:

- Night shifts are required; flexibility in working hours is essential.
- Work is performed in a manufacturing environment with occasional lab-based tasks.
- May require extended night shifts depending on production schedules.
- Strict adherence to safety standards, including wearing protective equipment.

**Physical Requirements**:

- Ability to stand or move for extended periods during night shifts.
- Ability to handle and operate laboratory and production equipment.

Pay: ₹9,713.45 - ₹31,728.60 per month

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

Work Location: In person