1. Responsible for GMP/QMS/Hygiene/Good documentation practices compliance for area of assigned activity.
2. To remain all time alert and responsible to ensure truthfulness of data for area of assigned activity as doer or checker..
3. Responsible for preparation and archival of APQR (Annual Product Quality Review).
4. Responsible for approval and distribution of shade card.
5. Responsible for sending the couriers ( National & International ).
6. Responsible for review of BMR and BPR.
7. Responsible to ensure he is trained and qualified for the activities of assigned responsibility.
8. To strictly follow master documents (BMR,BPR,QSD)instructions. In case of any issue raise deviation /change control for investigation and taking remedial action.
9. Any other job assigned time to time as and when required.
Salary: INR 1,00,000 - 3,00,000 P.A
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Quality Assurance/Quality Control Executive
Role: Quality Assurance/Quality Control Executive
The Ace unit of Ind Swift Limited was created in the year 2005 with an aim to globalize the Ind Swift brand for finished dosage forms. The manufacturing site catering to the demand of the developed international markets was commissioned in 2006. A record was created when two major regulatory approvals, one from MHRA, UK and the other from TGA, Australia were received for this site within a record time of the site being commissioned. The approvals opened the gates for GBU to become a key supplier of products to the countries of EU, Australia, Canada, Singapore etc.
The initial set up had the manufacturing lines set up for oral solids to be given in the form of tablets and hard gelatin capsules with a limited capacity. GBU has to leap into an expansion mode within a short time frame to be able to cater to the demands of the customers across the target markets and started expanding its capacities in line with the customer demands. The following years saw addition of new customers with GBUs increasing reputation as a company that was able to meet all the desired quality and supply standards across the world. On further consumer demand, GBU moved on the value chain to include a sachet packing facility in its premises which was again approved by all the regulatory authorities. ISL, GBU is one of the facilities that can provide specific environmental conditions for highly sensitive products.
The products from GBU are now available in more than 30 countries across the world spanning the countries of EU, Australia, Central & Latin America, Asia, CIS and Africa. The product selection for the various markets is based on the patent expiries in the developed countries and the high growth therapeutic segments like Cardiology, Diabetology, Osteoarthritis etc in the emerging markets.
Branch offices in Singapore, Dubai and China underline GBU's direct market presence in key regions.
With the increasing regulatory demands from across the globe, GBU is geared up to handle all kinds of queries from the Ministry of Health of different countries and has about 300 products registered globally with another about 500 in the pipeline. Each product registration in a country gives a thrust to our business. GBU has regular audits from the country and company representatives and is always honored for the GMP standards that are maintained.
GBU today partners with the leading generic players in all the countries. The commitment to Supply chain excellence, cost competitiveness and a Total Quality Management program which is driven by systems has allowed GBU to be recalled as a 'Supplier of Choice' on all occasions.
A cohesive team has allowed GBU to move ahead in its path at an unimaginable pace. The turnover of the GBU is slated to touch USD 40mn with only 5 years of commercial operations. A glance at the following figures clearly showing a targeted and achievable growth of more than 100% in this Year (having completed 50% of the sales in the 1st five months of the year which is generally a rare instance in any industry around the world) establishes it all.
The focus of GBU for the prospective years is clear and the ground has already been laid. The markets where the attention will be centered for future growth are GCC, MENA, Brazil, Mexico, Africa, Russia and the CIS countries. GBU has already received the regulatory approvals from the MOH- UAE, GCC, Anvisa-Brazil and is now building the product portfolio for specific markets. The business models to be followed would include licensing and supply arrangements and marketing of our own brands in these countries by setting up representative offices.
Tough and Rough market and regulatory environment are not a deterrent for GBU but a challenge to overcome and create a sustainable niche.