Process Associate

Avani Consulting; Mysuru; Vor Ort; INR 300.000 - 450.000; Vollzeit

Zusammenfassung

Avani Consulting is seeking a Production Associate for Mysuru (Nanjangud) with 3+ years in API production. The role focuses on batch planning, GMP compliance, and safe manufacturing practices on the shop floor.

You will ensure process adherence, document control, and coordination with QA for batch release and investigations as needed.

Qualifikationen

• 3+ years in production in API manufacturing.
• Education: B.Tech in Chemical Engineering and MSc in Chemistry.
• Location: Mysuru (Nanjangud)

Aufgaben

• 1. Production planning & execution of batches per commitments and cGMP & safety.
• 2. Ensure gowning, entry/exit procedures, PPE usage by team.
• 3. Adhere to process instructions as per Batch Manufacturing Records.
• 4. Maintain good housekeeping on production shop floor.
• 5. Comply with cGMP, Safety, Health & Environment in delivering quality product.
• 6. Review batch records for adequacy before QA release/reject.
• 7. Report deviations/incidents and investigate with cross-functional teams.
• 8. Enter documents online with legible handwriting and dated signatures.
• 9. Monitor manufacturing environment and maintain daily log books.
• 10. Maintain preventive maintenance and calibrations of equipment.
• 11. Perform department sanitization.
• 12. Support QA in investigations (OOS, CAPA, deviations, deviations, recalls).
• 13. Label and store raw materials/intermediates/api at each stage.
• 14. Reconcile stocks regularly.
• 15. Any other tasks assigned by Production head.

Kenntnisse

Production planning

Batch manufacturing

cGMP compliance

Quality assurance

Safety compliance

Ausbildung

B.Tech Chemical Engineering

MSc Chemistry

Jobbeschreibung

Hi,

Greetings from Avani consulting !!

We have opening for Production Associate role in Mysore location.

Exp : min 3 yrs in Production in API Mfg Industry

Education: B.tech Chemical. Msc chemistry

Work Loc- Mysuru (Nanjangud)

Interview Mode

• First Round - Virtual
• Second Round- F2F

Referrals most accepted and preference given.

Job Description

1. 1. Responsible for appropriate production planning & execution of batches in line with

   targeted commitments complying cGMP& Safety requirements.

2. 2. To ensure gowning practices, entry / exit procedures, usage of PPEs are followed by

   team while in the department.

3. 3. To ensure adherence of process instructions as per Batch Manufacturing Record and

   respective departmental procedures.

4. 4. To ensure good housekeeping in the production shop floor.

5. 5. To ensure compliance to cGMP, Safety, Health & Environment in delivering the

   product of intended Quality.

6. 6. To ensure batch records on completion are reviewed for adequacy prior to hand over to

   QA for review, compliance & release / rejection.

7. 7. To report deviations / incidents immediately upon occurrence and to conduct

   investigation in coordination with cross functional teams.

8. 8. To ensure all document entries are performed online with legible, errors corrected with

   signature and date.

9. 9. Monitoring and control of manufacturing environment and filling of daily log books.

10. 10. To ensure preventive maintenance of equipment, calibrations of gauges / instruments

    are performed as per schedule & the outcome of verification is within control.

11. 11. To ensure the sanitization activity is performed in the department.

12. 12. To support QA in investigations related to OOS, Deviations, CAPA, Incidents,

    complaints or recalls, validations and any other support that would be required.

13. 13. To ensure the raw material / Intermediates / API(s) are labelled at each stage of

    process and stored with appropriate segregation at recommended storage conditions

    ensuring no impact on product Quality.

14. 14. To ensure that stocks are reconciled at regular intervals.

15. 15. Any other assignment allocated by Production head.