Ipqa Chemist

Department
- MORAIYA QA
- Job posted on
- Jun 06, 2025
- Employment type
- P-P8-Probationer-HO Executive

**Role name: QA Chemist (IPQA)**
- **Division - Moraiya**:

- **Department - QA**:

- **Category - Staff**:

- **Qualification - B.Pharma/M.Pharma**:

- **Experience - 3 - 8 Years**:

- **Zydus Experience - Must have completed at least two PMS cycle.**

**Responsibilities**:

- Monitor the manufacturing processes to ensure that the drug product is manufactured as per procedure mentioned in respective Batch Record and SOP with proper documentation.
- Proper planning of available manpower to ensure that there is no manufacturing process loss or delay.
- Ensure that Line clearance of area, equipment and instruments is carried out competently.
- Ensure that the product is manufactured as per defined specifications.
- Ensure collection of in process samples, finished product sample, QP sample, Stability sample and any other samples as per approved sampling protocol and SOP.
- Monitor Hold Time study and Swab sampling as per approved protocol and SOP.
- To ensure proper handling and correct usage of respective process materials.
- Review/approve master batch records, SOPs, protocols, reports, risk assessment, self-inspection reports and other applicable documents.
- Review/verify/approve all the relevant documents as per procedure defined in respective SOPs.
- To ensure proper recording of necessary data, including process parameters and test results.
- To ensure proper handling of the in-process rejections, batch rejections and scrap as per SOP.
- Perform the Batch Release Activity for Exhibit and commercial Batches.
- To perform periodic inspections of the manufacturing areas, equipment, and facilities to identify and address any non-compliance issues.
- To escalate the issues related to the Process, Product, Quality, Cleaning or documentation related activities to immediate superior and take appropriate action related to it.
- To escalate any failures and overdue activity that can have a potential impact on product quality to immediate reporting authority.
- Ensure collection of RFT data and trending of the same.
- To Participate/facilitate cross-functional investigations.
- To ensure and impart training of SOPs and other necessary trainings to all concern personnel.
- To represent in the internal/ external Audits and to participate in the self-inspection activities.
- Responsible for initiation and review of Investigation reports pertains to deviations, Out of specifications, Out of trend and others if any.
- Responsible for initiation, review of change controls, CAPA and ensuring completion of action items.
- Perform SAP transactions as per requirement.
- Ensure Current Good Manufacturing Practices (cGMP) are followed in the facility.
- Report accidents and unsafe conditions or unusual circumstances to reporting manager.
- Other duties, which may be assigned from time to time, by reporting manager.

**Essential job requirements**:

- Understand the purpose and function of the respective area, equipment and operations.
- Co-ordination with Subordinates and other departments.
- Understands the Good Documentation Practices, ALCOA policy.
- Strong attention to detail and ability to identify discrepancies, deviations, and non-conformances
- Problem solving Skills.
- Ability to make timely and well-informed decisions.
- Comply with the Privilege rights matrix (PRM) of the Organization.