Associate - Ipqa/qms

2 days ago

Chennai, India Levim Biotech Full time

**JOB DESCRIPTION IPQA**
- Ensure compliance to cGMP for all operational activities.
- Issuance and retrievals of Batch Manufacturing records
- Review of the executed Batch Manufacturing records for compliance to the requirements.
- Line clearance for product changeovers and packaging activities
- Ensure the sampling of intermediate and finished product samples as per SOP and BMR
- Verify environmental and personnel monitoring
- To control the inventory of control samples.
- To co-ordinate the Qualification / Validation of the Equipment, Systems and Process.
- Planning routine activities in IPQA as well as timely ensure line clearance in the warehouse and production area.
- Maintaining all observations & records of in-process check to assure and increase the product quality.
- Coordinate in the dispatch activities and maintain records
- Daily rounds and monitoring of the shop floor (Production Warehouse and Engineering) activities to ensure the compliance with requirements

**JOB DESCRIPTION QMS**
- To co-ordinate the Qualification / Validation of the Equipment, Systems and Process.
- To ensure the Analytical method validation of cleaning process before conducting Cleaning validation.
- Preparation of Cleaning Validation Master plan.
- Preparation and Execution of Cleaning validation protocols.
- Cleaning Validation Analytical Data collection and Summary report preparation cleaning validation.
- To conduct or organise revalidation activity at the defined frequency.
- To conduct audits and periodic visit for contract manufacturing and testing organization.
- Review & Investigation of quality complaints for products manufactured at contract manufacturing locations.
- Involve in failure investigation of products manufactured at contract manufacturing sites and prepare reports accordingly.
- Initiation and follow-up of market complaint CAPAs.
- Review of Deviations and Change controls and to ensure closures.
- Responsible for supporting contract manufacturing locations for effective implementation of Quality management system as applicable.
- Supplier evaluation.
- Responsible for identification, assessment and mitigation of risks within the Quality Operations.

Work Remotely
- No

**Salary**: From ₹11,500.00 per month

**Benefits**:

- Health insurance
- Leave encashment
- Provident Fund

Schedule:

- Rotational shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Chennai - 600113, Tamil Nadu: Reliably commute or planning to relocate before starting work (preferred)

Application Question(s):

- Mention your highest qualification
- How soon you can join with us if you are selected

**Education**:

- Bachelor's (preferred)

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