Quality Assurance Officer

3 days ago

Ankleshwar, India Orbitouch Outsourcing Pvt ltd Full time

Designation - Sr. QA Officer

Experience - 3 to 4 years in Api pharma no more this.

Salary - 3 to 4.5 lakh

Qualification -BSc /MSc Chemistry/ B. pharma

Location - Ankleshwar, Bharuch.

**POSITION: Sr.QA Officer**

**RESPONSIBILITIES**:

- To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material.
- Assistance in preparation of SOP of various departments/ preparation of draft SOPs.
- During plant round QA Executive to verify documents as per cGMP and GLP norms.
- Line Clearance activities for manufacturing and packaging before process starts.
- To issue the deviation form, Change control form, Out of Specification form, Customer complaint form, OOT form, investigation for etc. as per request from respective dept.
- Review and verification of Analytical and Batch Manufacturing Record and filing BMR. QA verification and release of finish product.
- To prepared documents & records and monitoring of activities as per SOPs
- Distribution, retrieval and control of SOPs, documents/records of all dept.
- To participate the internal audits, customer audit, regulatory inspection.
- To Attend QR meeting as per schedule.
- To ensure data integrity as per procedure.
- To review manufacturing, store, QC activity.
- To prepare approved vendor list and maintain vendor qualification.
- Conduct traceability Activity.
- Preparation and maintain CAPA log.
- To ensure that deviations, product recall, return goods and customer Complaints, OOS, OOT by CAPA and Root Cause analysis are investigated, fill up of report and log the same.
- To collect data and prepare the annual product review.
- To witness and verify of process validation, cleaning validation and equipment qualification and to prepare protocol and report.
- Returned Material: Investigate and make investigation report and maintain the record.
- Product complaint: Investigate and make investigation report and maintain the record.
- Ensuring compliance of the systems used for maintaining the equipments and calibrating equipment /instruments/ preparation of schedule.
- To prepare template or record format as per respected SOP and issuance.
- To prepare a schedule and conduct training on cGMP, GLP and evaluation of the training.
- Providing training to all concerned on cGMP and on job specific or based on needs identified.
- Any other assignment /work allocated by Head QA.
- To ensure disposal of waste is carried out as per procedure.
- To Support the head of department in the environmental management work and reporting to head of Department with regard to how the environmental management work is continuing.
- Investigation of deviation/ incident related to Environment management with co-ordination with head of department.

**Industry Preferred
- Api Pharma**

**Job Types**: Full-time, Permanent

Pay: ₹450,000.00 per year

Schedule:

- Day shift

Application Question(s):

- What is your Current Location?
- What is your Notice Period?
- What is your Current CTC?
- What is your Current Expected CTC?

**Experience**:

- Quality assurance: 3 years (required)
- API Pharma: 3 years (required)

Work Location: In person

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