United States
Sector
Keyword
Quality Assurance Chemist
QA Pharma
Pharma QAQuality Chemist
Chemist Quality Management
QA Chemist
QA Executive Pharma
Officer QATeam Member Quality Assurance
Quality Assurance Scientist
QA Lab Chemist
Minimum B. Pharma/B. Science Or M.Pharma/M.Sc. (preferably Chemistry)Certified training for Quality Assurance Chemist (programme aligned to LFS/Q 0301 released by Life Sciences Sector Skill Development Council)
Preferably 2 years in production/quality control in case of B. Pharma/B.ScIn case of M.Pharma/M.Sc. no prior experience is required
The tasks a Quality Assurance Chemist is expected to perform include: Conducting pre, post and in-process quality checks to ensure compliance with regulatory standards and procedures
Conducting self-inspections and qualification activities during installation of new equipment and other analytical instruments
Monitoring documents and data control for processes, validation and qualification activities of machines
Checking and verifying material, quality management systems and manufacturing facility
Monitoring and reviewing batch manufacturing, packing documents, analytical records, good manufacturing practices, etc.Managing activities such as audits, regulatory agency inspections or product recalls
Identifying and developing appropriate quality monitoring arrangements and maintaining standard operating procedures
Maintaining a healthy, safe and secure working environment
Co-ordinating with the Supervisor and other team members
Knowledge of the composition/requirements of the products manufactured and packaging specifications for different products
In-depth understanding and knowledge of regulatory requirements, good manufacturing practices, acceptance criteria and standard operating procedures
Expertise in qualification and validation procedures
Detailed knowledge of regulatory audits1 year of training for entry level Chemist is mandatory GXP (GLP, GDP, GMP)Knowledge of pharmaceutical industry, government rules and regulations and standards of manufacturing
Basic knowledge of formulation and APIBasic understanding of the fundamental science of API production
In-depth knowledge of various QMS for pharma manufacturing
Basic knowledge of various documentation as per GMP and QMS guidelines Ability to analyse data, pharmaceutical analytics and process safety analysis
Knowledge of safety and how to handle an emergency/hazard
Knowledge of job safety analysis for various production machines and equipment
Knowledge of how to conduct audits and audit reporting
Knowledge of chemical substances, their characteristics and required precaution and safety measures
Knowledge of analytical equipment like HPLC, UV, GC, IR, NMR, etc.
Attention to detail
Communication skills
Problem solving skills
Decision-making skills
Planning and organizing skills
Analytical and critical thinking skills
Collaboration
Reflective thinking
Customer Centricity
It is not only a desk job
Need not handle a team
Travelling is required Part-time work is available
Work from home option is not available
Working hours
Work is minimum 8 hours everyday for 6 days a week
Some jobs involve working in shifts including night shifts
Is the job suitable for a candidate with special needs?Maybe
This job is not considered hazardous or dangerous
Occupational hazards include injury through sharp objects, burns, chemical leakage, electricity, etc. Health risks inhaling and constant exposure to chemicals, gases, etc.
For freshers -INR5,000 toINR8,000 per month
For candidates with upto 2 yearsexperience -INR8,000 toINR12,000 per month
For candidates with over 2 yearsexperience ?INR12,000 toINR25,000 or above per month
(These figures are indicative and subject to change)
Life Sciences Sector
India?s Pharmaceutical Industry
India's drugs and pharmaceuticals industry is expected to grow at a compound annual growth rate (CAGR) of 14 per cent to reach a turnover of 2.91 trillion (US$ 47.06 billion) by 2018.
The domestic drugs industry, which is valued at 1.6 trillion (US$ 25.87 billion) at present, according to Care Ratings, is also expected to grow in the local market with aggressive rural penetration by drug makers, increased government spending on health, and growing health awareness among people.
India exports pharmaceutical products to more than 200 countries. Pharmaceutical exports are expected to cross the 1 trillion (US$ 16.17 billion) mark this year. "The growth would be around 15 per cent and is driven by formulation exports," said Dr PV Appaji, Director-General, Pharmaceutical Export Promotion Council (Pharmexcil). During 2013-14, pharma exports stood at?90,000 crore (US$ 14.55 billion). Out of this, the share of formulations was 71 per cent.
India currently exports drug intermediates, Active Pharmaceutical Ingredients (APIs), Finished Dosage Formulations (FDFs), bio-pharmaceuticals, and clinical services across the globe.
Apart from medicine, the life science sector also branches out into various other sub-sectors viz. bio-pharma, research, etc. There are numerous companies and organizations which have devoted their time and resource to bio-pharma. Research is another area where a Quality Assurance Chemist can offer his/her expertise. Since these are emerging sectors, they are growing in popularity. All these factors put together will have a positive trickle-down effect on the available job opportunities for a Quality Assurance Chemist.
Indian API Industry
The generic APIs market is expected to continue to rise faster than the branded or innovative APIs, by 7.7 per cent per year and is expected to reach $30.3 billion in 2016. Asia-Pacific is expected to show the fastest growth rates of 10.8 per cent per year. The 24 fastest growing markets will include 11 in Asia-Pacific
Pharmaceutical/chemical manufacturing companies
Job opportunities are available across India with a higher concentration in Uttarakhand, Himachal Pradesh, Haryana, Karnataka, Maharashtra, Gujarat etc.
Job opportunities are available in areas where pharmaceutical/chemical production companies have their set-up
Affiliated Training Partners of Life Science Sector Skill Development Council
List.aspx
The National Skill Certification and Monetary Reward Scheme
http://nscsindia.org/NSCSTraining
Partners.aspx