Production Officer - Injectable

Key Responsibilities:

· Batch Preparation:

This involves preparing solutions, weighing ingredients, and ensuring proper mixing according to batch records and SOPs.

· Aseptic Filling:

This includes operating filling machines, maintaining sterile environments, and ensuring proper filling of vials, ampoules, or other containers.

· Sterilization:

This involves using autoclaves, dry heat sterilizers, or other methods to sterilize equipment and containers, and monitoring the process.

· Aseptic Maintenance:

This includes maintaining the cleanliness and sterility of equipment and work areas, and performing environmental monitoring (e.g., particulate monitoring).

· Quality Control:

This involves performing in-process checks, such as pH, volume, and sealing checks, and maintaining accurate records.

· Documentation:

This includes maintaining accurate batch records, logbooks, and other documentation related to production.

· Equipment Operation and Maintenance:

This involves operating and maintaining various equipment used in the sterile injectable manufacturing process, such as filling machines, autoclaves, lyophilizers, and water systems.

· Compliance:

Adhering to GMP guidelines, SOPs, and regulatory requirements.

· Troubleshooting:

Identifying and resolving issues related to equipment, processes, or quality.

· Training:

May be involved in training other personnel on production procedures.

Required Skills and Experience:

· Experience in sterile manufacturing: Hands-on experience in a sterile injectable manufacturing facility is often required.

· Knowledge of aseptic techniques: Understanding of aseptic principles and practices is essential.

· Familiarity with equipment: Experience with equipment used in sterile injectable manufacturing, such as filling machines, autoclaves, and lyophilizers.

· Knowledge of GMP and regulatory requirements: Understanding of GMP guidelines and relevant regulatory requirements (e.g., FDA, MHRA).

· Documentation skills: Ability to maintain accurate and complete production records.

· Problem-solving skills: Ability to identify and resolve issues related to production.

Education:

· A bachelor's degree in pharmacy, biology, chemistry, or a related field is often required.

· Experience- 2 to 3 years.

Job Types: Full-time, Permanent

Benefits:

• Paid sick time
• Paid time off
• Provident Fund

Schedule:

• Day shift
• Morning shift

Work Location: In person