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production documentation and QA documentation

2 months ago


Hyderabad, India Stanex Drugs & Chemicals Pvt. Ltd. Full time

Company Description

Established in 2009, Stanex Drugs & Chemicals Pvt. Ltd. is a Sterile Injectable Manufacturing Facility in Hyderabad. Specializing in Liquid Injectables, Lyophilized Products & Pre-Filled Syringes, we uphold "Russian GMP" & ‘WHO GMP’ standards to be a leading player in the pharmaceutical and healthcare space. Our international vision drives us to be a key player in the industry through cost-effective manufacturing and third-party agreements.


Role Description

This is a full-time on-site role for a Production Documentation and QA Documentation professional at Stanex Drugs & Chemicals Pvt. Ltd. The role involves tasks such as production planning, quality control, production management, training, and effective communication to ensure production efficiency and quality standards are met.


Qualifications for Production

1. Preparation of BMR and BPR

2. Review of BMRs 

3. Preparation of batches

4. Validation execution of vial washing, tunnel, filling and sealing

5. Ensuring maintenance of Asceptive conditions during manufacturing

6. Media fill executions

7. Coordination with warehouse and QC for batch planning and batch testing.

8.Bpharma or Mpharma is acceptable.


QUALIFICATION FOR QA

  1. Review of BMRs.
  2. Qualification Documents: Tunnel, Vial washing, Filling, Sealing
  3. Media fill execution
  4. Change Control and QMS handling
  5. Deviation filling


Assistant manager and Senior Executive Positions are available