Walk-in For Quality Assurance, Microbiology And Production Department At Hetero Biopharma

Walk-in interviews

Interview & Work Venue :

Hetero Labs Limited (UNIT VI), Polepally, Jadcherla, Mahabubnagar, TS, INDIA - 509301

What to bring to the interview:

Academic documents, Pay slips, Appointment letters, CTC particulars, ID proof, Bank Statements, and Previous Releaving Letters

E-mail: Harishwar.M@hetero.com for further info.

Interview date: 07-Dec-2024(Saturday) Time: 9.00 a.m. to 2.00 p.m.

In the pharmaceutical industry, Quality Assurance (QA), Microbiology, and Production departments play vital roles in ensuring that high-quality, safe, and effective products are manufactured. Here's a detailed breakdown of each department and their responsibilities:

1. Quality Assurance (QA)

Role: QA ensures that quality is built into every stage of the manufacturing process, from raw materials to the final product.

Responsibilities:

Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, WHO, EU-GMP).
Approve Standard Operating Procedures (SOPs), batch manufacturing records, and validation protocols.
Oversee process validations, cleaning validations, and equipment qualifications (IQ, OQ, PQ).
Handle deviations, non-conformances, and CAPA (Corrective and Preventive Actions).
Conduct internal audits and coordinate external inspections.
Ensure training and competency of personnel on GMP and SOPs.
Oversee product release after thorough review of manufacturing and QC data.

2. Microbiology Department

Role: The microbiology department ensures that products meet microbiological standards, preventing contamination that could affect product safety and efficacy.

Responsibilities:

Perform microbiological testing of raw materials, water, in-process samples, and finished products.
Conduct environmental monitoring of production areas (air, surfaces, personnel).
Validate sterilization and cleaning processes.
Test for sterility, endotoxins, and microbial limits, especially for sterile dosage forms.
Monitor water systems, ensuring compliance with pharmacopeial standards (e.g., USP, EP).
Validate aseptic processes and ensure adherence to proper gowning procedures in cleanrooms.
Investigate microbial contamination and propose corrective actions.

3. Production Department

Role: The production department is responsible for the manufacturing of pharmaceutical products while adhering to GMP and ensuring efficiency and quality.

Responsibilities:

Execute the manufacturing process as per approved Batch Manufacturing Records (BMRs).
Ensure proper handling and mixing of raw materials.
Maintain all equipment in validated conditions and ensure proper calibration.
Monitor critical process parameters (temperature, pressure, mixing time, etc.) to maintain product consistency.
Perform in-process checks, such as weight variation, hardness, and content uniformity.
Ensure compliance with safety and hygiene protocols.
Work closely with QA and QC to resolve any process deviations or quality issues.
Maintain production logs and ensure traceability of materials and processes.

Interdepartmental Collaboration

QA and Microbiology: QA ensures microbiological tests are part of quality standards. It also reviews microbiology results for compliance.
QA and Production: QA monitors production activities, approves batch records, and ensures all processes meet quality standards.
Microbiology and Production: The microbiology department ensures the production environment and water systems are free from contamination, supporting sterile or non-sterile manufacturing.