What is Quality Assurance profile in Pharma Industry?

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Ask BioTecNikaWhat is Quality Assurance profile in Pharma Industry?
Vaijanath Bande asked 1 year ago

complited in graduate in Bsc Agri. Biotech 3 yr exprience in seed industry

2 Answers
Ria Roy Staff answered 1 year ago

Quality Assurance or QA is a very important department of the pharmaceutical sector. This department’s aim is not only testing but to supply a remarkable high quality of the final product to the market. The quality of pharmaceutical products has been a major concern of WHO. Drugs have to be marketed as much safer as well as therapeutically active types. QA suggests inspecting the grade of quality of products and also procedures employed for the manufacture of them.
QUALITY: Quality is the measure of excellence or a state of being free from defects, deficiencies and significant variations.
QUALITY ASSURANCE: Obtaining confidence that, the required quality of product or service is satisfactory for their intended use.
QUALITY CONTROL: Part of GMP concerned with sampling, testing, and specifications.
The pharmaceutical environment today is changing rapidly due to globalization, increased competition, expense restraints, needs for performance, growth of global guidelines, supply chain complexity, and also product/process intricacy. In this fast-changing environment, individuals and firms that find out to adapt will certainly thrive.

Career prospects of Quality Assurance: Functions of Quality Assurance Specialist in Pharma ;
  • To Ensure: Raw materials used in the manufacturing are approved and procured from
    approved vendor.
  • All data are recorded as per cGMP and is reviewed for accuracy and
    traceability.
  • To prepare and approve Quality Policy, Quality Objectives, Quality Manual and
    Validation Master Plan.
  • Periodic Monitoring of the Quality Objectives.
  • Monitors all validation & stability activities are completed as per the schedule.
  • Ensures that all changes impacting the product and the established systems are
    documented and reviewed to analyze the impact
  •  Ensures that all deviations, OOS/OOT & Market complaints are logged,
    investigated to identify the root cause so as to take CAPA to prevent
    a recurrence.
  • Preparation of Annual product quality reports, trending of data, determining
    product and process performance.

Image result for pharmaceutical industry gifs

  • To arrange and conduct the self-inspection, identify gaps and take CAPA.
  • Review of related batch manufacturing records and QC testing data Prior to
    the release of any batch.
  • procedures are in place for performing the activities, operating and
    calibrating the equipment
  • Quality is built up in the plant, process, product. That a Robust Quality
    the system is in place
  • To manufacture & provide continually zero-defect items to the clients.
  • The top quality, effectiveness and also security characteristics of items need to be made sure to make sure that consumer health and wellness isn’t compromised.

Some pharmaceutical industries have both Quality Assurance and also Quality Control departments, are considered as the same system but most of the markets considered them as different devices and contain different locations for both. QC is in charge of monitoring all aspects related to items. For eg., QC of aerosol involves monitoring of propellant, checking of container, valve, high quality as well as life expectancy energetic concentrate and so on. And QA of very same is checking of products which are passed by the QC department. They will certainly examine all the limits as well as formulas gone by QC. So, we can construct from below that exactly how important QA is.
Image result for qa department in pharmaceutical industry SLIDES
In pharmaceutical industries, Quality Assurance specialists are most welcomed with eye-catching salary. The important point is understanding of logical skills and also experience of collaborating with any type of pharmaceutical market is required. It is very accountable work. We currently know that small errors can make many losses. Quality assurance is a large concept that covers all facets that jointly or individually impact the high quality of the product. Quality control is an excellent method in the manufacture of pharmaceutical products, as it is the procedure of guaranteeing the integrity of items to meet the standard for the proposed use.
The average salary for a Quality Assurance Specialist in India is Rs 488,009 per annum. Experience strongly influences pay for this job.

suphiya Staff answered 1 year ago

Dear Vaijanath,
Biotechnology is a research oriented field. So, getting a good job will be a time taking process, one cannot simply think of a good job simply by completing the Bachelors degree. For good job prospects one must have a Masters degree and preferably a PhD degree. For a PhD degree one has to qualify some entrance exams like CSIR NET, JGBEEBILS, DBT JRF, ICMR JRF etc. So please try to prepare and get into some good college for brighter job prospects.
However as a Biotechnology graduate fresher, you can try to join some research institute in some project, join some pathology labs, try in pharma companies, QA/QC jobs or in the healthcare sector. You can even join as a Lab technical associate in any institute or hospital.You can also try to join in some college as academic support and then pursue your Masters and higher degree simultaneously, though a full time course has more weightage and is the one that is often required.
Vaijanath, it is good that you have an experience in the seed industry, it might give you an upper edge over other candidates while applying for research positions.
For jobs in the field of Biotechnology, you can subscribe to BioTecNika Times, where you will get all the latest updates about the jobs as well as PhD openings in the field of Microbiology, Biotechnology and Life Sciences.
All the best

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