Job Description

Job Title:

Production Chemist - Pharmaceutical Injectable Unit

Job Responsibilities:

Formulation and Manufacturing:

Oversee and manage the production of injectable pharmaceutical products according to established Standard Operating Procedures (SOPs). Ensure proper formulation of injectables, including mixing, dilution, and sterilization processes. Monitor and ensure the correct preparation of raw materials and reagents for the injectable production process.

Quality Control and Compliance:

Ensure that production processes comply with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory standards such as FDA, EMEA, and ICH guidelines. Conduct in-process testing to monitor and verify the quality of the product during production. Maintain and monitor batch records, ensuring accuracy and compliance with internal procedures and external regulatory requirements.

Equipment and Facilities Management:

Operate and maintain production equipment, ensuring it is calibrated, cleaned, and validated according to standards. Perform equipment troubleshooting and assist in preventive maintenance activities. Ensure the sterile environment in the injectable unit is maintained, complying with aseptic conditions.

Troubleshooting and Optimization:

Identify and resolve any issues that may arise during production, including troubleshooting equipment malfunctions or deviations in processes. Continuously assess and recommend improvements to the production process to enhance efficiency, reduce waste, and improve product quality.

Documentation and Reporting:

Maintain detailed and accurate documentation for batch production records, test results, and process conditions. Prepare and review production and compliance reports as required by management and regulatory authorities. Ensure all records are accurate and completed in accordance with audit and regulatory requirements.

Collaboration and Training:

Collaborate with cross-functional teams including Quality Assurance (QA), Quality Control (QC), and Engineering to ensure smooth production operations. Provide guidance and training to junior chemists, operators, and technicians within the production team.

Safety and Regulatory Adherence:

Ensure that all safety and environmental guidelines are followed within the production area. Participate in audits and inspections by regulatory authorities and internal teams.

Qualifications:

Educational Requirements:

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related field. A Master's degree or relevant certification (e.g., in GMP or pharmaceutical manufacturing) is a plus.

Experience:

3-5 years of experience in pharmaceutical manufacturing, particularly in sterile injectable production. Experience with aseptic techniques and understanding of the specific challenges of injectable production. Familiarity with regulatory standards and compliance such as GMP, ICH, and FDA regulations.

Skills:

Strong knowledge of pharmaceutical manufacturing processes, particularly for sterile products. Excellent attention to detail and ability to maintain accurate records. Proficiency in using laboratory and production equipment. Strong problem-solving skills, analytical thinking, and troubleshooting abilities. Good communication skills to collaborate effectively with team members and other departments. Ability to work under pressure and meet deadlines.

Certifications (optional but beneficial):

GMP (Good Manufacturing Practice) certification. Aseptic processing and sterility assurance training.

Working Conditions:

The role may require working in controlled, sterile environments. This is a hands-on role that may require standing for long periods and handling equipment. The production unit operates under strict cleanliness and safety protocols.
This role is essential for ensuring that pharmaceutical injectable products meet the required quality standards while adhering to regulatory guidelines and maintaining safe production practices.

Job Types: Full-time, Permanent

Pay: ?25,000.00 - ?40,000.00 per month

Benefits:

Cell phone reimbursement Food provided Health insurance Internet reimbursement Leave encashment Life insurance Provident Fund
Schedule:

Day shift Morning shift Rotational shift
Supplemental Pay:

Performance bonus Yearly bonus
Education:

Bachelor's (Preferred)
Experience:

pharma, Injectable production: 3 years (Required) pharma production: 3 years (Required)
Work Location: In person