The Equipment Validation Chemistare responsible for carrying out documented evidence that the equipment used throughout in the manufacturing process will produce products/drugs as per the laid norms and standards.
Brief Job Description: : The Equipment Validation Chemist assists in executing and performing qualification studies to document evidence for providing assurance that equipment will consistently produce products that meet the predetermined specifications, quality attributes, quality standards and regulatory standards.
Personal Attributes: The individual should have good knowledge of standard documentation procedures, rules, regulations and statutory requirements in preparation of scientific documents. The individual must demonstrate attention to detail and proactive behaviour.
| Qualifications Pack Code | LFS/Q0312 | ||
|---|---|---|---|
| Job Role | QA Chemist- Equipment Validation – Life Sciences | ||
| Credits(NSQF) | TBD | Version number | 1.0 |
| Industry | Life Sciences | Drafted on | 15/12/14 |
| Sub-sector | Pharmaceutical and Biopharmaceutical | Last reviewed on | 26/03/15 |
| Occupation | Quality | Next review date | 01/06/17 |
| NSQC Clearance on | 20/07/2015 | ||
| Job Role | QA Chemist- Equipment Validation – Life Sciences |
|---|---|
| Role Description | Responsible for executing and performing qualification studies to document evidence for providing assurance that equipment will consistently produce products that meet the predetermined specifications, quality attributes, quality standards and regulatory standards. |
| NSQF level | 5 |
| Minimum Educational Qualifications | B. Pharma / B.Tech Chemical / B. Sc with Chemistry major subject (Preferable) |
| Maximum Educational Qualifications | M. Pharma/ M.Tech Chemical/ Quality related certification/ M.Sc with Chemistry as major |
| Training(Suggested but not mandatory) | On the job training |
| Minimum Job Entry Age | 20 Years |
| Experience | 0-2 Years |
| Performance Criteria | As described in the relevant NOS units |