Stability Program is a key quality program managed/maintained and handled within the Quality Assurance department at Avet. Responsibility typically includes review of tasks to look after the entire Stability Management as defined below:
• This position has no direct reports.
01. Determine whether quality activities and related results comply with cGMP requirements.
02. Perform and monitor all production floor QA related functions for Soft-gel Manufacturing process.
03. Perform and monitor all production floor QA related functions for manufacturing process for solid dosage (tablets and hard gelatin capsules) and drug product in powder form.
04. All the QA related functions required must be performed and carried out as per established company standard and procedures and assure that manufacturing/production is according to cGMP regulation.
05. The typical tasks/activity performed as the production floor QA are listed here but not limited to such as:
• Logbook maintenance on daily and calendar basis
• Providing required approval for production activity and make appropriate entries in respective batch manufacturing records/MMR.
• Verify raw material and components prior to usage as required and checking and monitor the dispensing/weighing process.
• Check cleanliness and provide usage approval of equipment and production rooms in production department namely granulation, Tableting, Encapsulation, Coating, Soft-gel and Packaging.
• Collect granulation, tablet, capsule, soft-gel and packaging samples at various stages of production.
• Perform and collect in-process samples e.g. for individual blend sample for uniformity, and composite samples and submit it for QC testing.
• Perform drying curve sampling and verification of moisture by Ohaus Moisture analyzer.
• Perform Hardness, AQL DT Friability and Thickness testing of tablets
• From QA perspective participate and monitor IQ-OQ-and PQ and Preventive maintenance of production equipment.
• Process validation, process characterization, cleaning validation and time limit validation monitoring
• Provide approvals for setup of machines and commencement of production.
• Assist packaging operation whenever required.
Specialized Skills and Knowledge:
• Minimum Associate degree with Chemistry as a major subject alternatively minimum 3-5 years of experience in the QA department of a pharmaceutical company handling stability and experience managing stability chamber.
1. Analytical Skills
2. Problem Identification and Solving Skills
3. Communication Skills in English
While performing the duties of this job, the employee is regularly required to mover around the production floor. The employee is regularly required to move around various buildings of Avet. The employee must occasionally lift and or move up to 25 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.
|Job Category||Quality Assurance|