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Monday, February 6, 2017

Trump Orders Agencies to Repeal Regulations, Reconsider Annual Compliance Costs












WASHINGTON — President Trump on Monday signed an executive order directing federal agencies to cut two regulations for every new one that they adopt, a move that could have significant implications for the Food and Drug Administration. 

Sunday, February 5, 2017

FDA cGMP violations which teach about cGMP and effective CAPA system


























FDA cGMP violations which teach about cGMP from where non GMP  activities went. Learn about effective CAPA system .

Saturday, January 14, 2017

Trump's $25 billion wall would be nearly impossible to build, according to architects

Trump's $25 billion wall would be nearly impossible to build, according to architects

Republican U.S. presidential nominee Donald Trumpspeaks as Democratic U.S. presidential nominee Hillary Clinton listens during their third and final 2016 presidential campaign debate at UNLV in Las Vegas, Nevada, U.S., October 19, 2016. REUTERS/Mark Ralston

In early January, President-elect Donald Trump revived his promise to build a wall along the Mexico-US border (as well as his disdain for the media).
"Dishonest media says Mexico won't be paying for the wall if they pay a little later so the wall can be built more quickly. Media is fake!" he tweeted on January 9.
The incoming administration may ask US Congress (and taxpayers) to foot the wall's bill, according to Republican lawmakers. Trump, however, said that Mexico would eventually pay for the project and reimburse the US. He and House Republicans are developing plans to fund the wall using taxpayer money through a 2006 law that put up 700 miles of barriers along the southern US border.
A substantial part of Trump's campaign focused on "the wall" and a deportation-centric, closed immigration policy. But now that he has won the election, it's still uncertain how anyone will actually build the 1,954-mile-long border wall.
Business Insider consulted a few architects to get some perspective on this question. They say the project would be nearly impossible (or, at the very least, unrealistic and a drain on US resources). Here are their reasons.
The cost will be huge.
As CityLab points out, Trump is pledging to construct the largest infrastructure project since the US highway system and the Erie Canal. He has shared few logistic details about how it will be built, except that Mexico will eventually pay for it (though, Mexican President Enrique Pena Nieto said his country refuses to foot the estimated $25 billion construction cost), after the US starts the construction.
This giant price tag makes the project immediately infeasible, Rosa Sheng, a senior architect at the San Francisco-based firm Bohlin Cywinski Jackson, tells Business Insider.
"The US [is] currently as a $19-plus trillion deficit. Rather than spending our country's resources on building a wall, we should be focusing our energy on building bridges - both literal and figurative," she says. This includes "infrastructure improvements and transportation in major cities that support interstate supply chains, and alternative green energy production that will address not only climate change, but also challenge our dependency on fossil fuels." said Trump's.

Source: Business Insider.

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Donald Trump’s words spook Indian pharma stocks



Donald Trump’s words spook Indian pharma stocks 

MUMBAI: United States president-elect Donald Trump’s bashing of the pharmaceuticals industry has pushed shares of Indian drug makers down, as a possibility of pricing pressure in their most profitable market looms over these companies. 

In his first press conference after electoral victory, Trump on Wednesday vowed to force the US drug industry to produce at home and cut prices. 

“Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don’t make them here, to a large extent. 
And the other thing we have to do is create new bidding procedures for the drug industry because they’re getting away with murder,” he said. 

Trump will officially take charge as the 45th President of the United States on January 20. 
His comments impacted share prices of Indian drug companies on Thursday and the Bombay Stock Exchange healthcare index closed 0.73% down at 15,012.24, as top companies such as Dr Reddy’s, Sun PharmaBSE 1.14 % and LupinBSE 0.35 % have significant exposure to the US market. 
Shares of Reddy’s closed 2% down at Rs 3,011 on the BSE on Thursday, while Lupin fell 2% at Rs 1,489 and Sun Pharma lost 0.59% to close at Rs 644. 

In his address Trump said even though the US is the largest buyer of drugs in the world, the country does not bid properly. It will soon start bidding in a way that would help it save billions of dollars over a period of time, he said. 

As companies prepare for third quarter results, analysts are being conservative with their.. Expectations for the sector. Brokerage firm Jefferies said it expects another muted quarter for the pharma sector led by weakness in US business. The overhang of regulatory inspection by the US drug regulator and pricing in US will dominate the results as it expects 12% revenue growth for Indian pharma with a margin decline of 100 bps. 

Some global peers have indicated that pricing is likely to remain under pressure in 2017 also,” Jefferies wrote in its research note. Another worry that Indian drug companies have is the ongoing investigation by the US department of justice into suspected collusion by drug companies to artificially inflate prices. 

Donald Trump’s words spook Indian pharma stocks 
Source: economictimes




(This story has not been edited by pharmanaukri staff and is auto-generated from a syndicated feed.) Disclaimer: The Logos/Images posted here are belongs to respective to Authority / owners of firm.

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Thursday, January 12, 2017

We proudly launched Pharma news and pharma Guidelines portal www.gmpviolations.com







Dear All,

Good News..

In addition to pharma jobs services Now on our new program for Knowledge sharing .....initiative...

We proudly launched Pharma news and pharma Guidelines portal.

www.gmpviolations.com


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Many More...





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Monday, January 2, 2017

The Flipkart Fashion Sale [3-5 Jan]- 10% Off with HDFC Credit Cards | Upto 80% Off on Fashion | Flat 5K Off on iPhone 6 & many more offers!

Image result for logo flipkart




BANK OFFER | HDFC Bank
Instant 10% Discount on Min. cart value of INR 1500 using HDFC Bank Credit Cards
  • 10% Instant Discount with HDFC Bank Credit Cards
  • Min. cart value : INR 1500 | Max. discount per card : INR 1500
  • Applicable on select products across Home & Lifestyle categories
  • Offer Period : 2nd Jan'17 (18:00 Hours) to 5th Jan'17 (23:59 Hours)

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Plant Head / Sr GM - Formulations / Pharma ( Tablets / Capsules) Chandigarh



Job Description:

Job Summary 

To plan, organize, direct and control manufacturing and related operations of large scale regulated Formulation / Pharmaceutical Manufacturing site, catering to the needs of USFDA, MHRA, KFDA, TAG, WHO markets

1. Preparation & execution of annual production budget, CAPEX. Support the product requirements of all marketing and sales divisions to ensure that products are produced according to plan 
2. Maintain appropriate inventory levels. 
3. Manage production expenses and maintain or reduce COGS. 
4. Responsible for maintaining quality standards to meet GMP requirements. 
5. Look after the FDA, MHRA, WHO and other regulatory Audits of the manufacturing facilities and processes. 
6. Interface with the statutory bodies and ensure statutory compliance.
7. Lead and manage major projects project for new as well as improving the existing ones
8. Manage good industrial relations , build an effective team for sustainable & superior performance

Job Description (KRAs)- 

Policies and Procedures: 
Direct and coordinate plant operations within company policies and procedures. Establishes and directs plant policies and procedures

Productivity: 

Accountable for meeting plant production goals set by the VP manufacturing through the manufacturing budget process.
Review, analyze, plan, coordinate and lead all activities within the manufacturing operations organization. Assure the development and coordination of systems and programs to promote cost effective manufacturing operations in line with manufacturing plans and objectives.
Support programs and procedures that provide reliable products with minimal quality control, repair, scrap and warranty expense. 
Assures attainment of programs and production schedules while insuring high quality standards.

Quality: 

Accountable for product quality control for the plant.

Planning: 
Develops and executes capital and expense budgets and operating plans under the guidance of General Manager.
Schedule and conduct plant meetings.
Initiate plans and processes which minimize manufacturing costs through effective utilization of manpower, equipment, facilities, materials and capital.
Assure development and execution of manufacturing schedules in conjunction with the Materials Manager.
Plan and implement manufacturing strategies and action plans to insure that the manufacturing operations group supports the strategic imperatives.
Monitor plant performance and communicate progress against objectives to management.
Confer with department heads to ensure coordination of sales and purchasing and logistics planning functions with site production, maintenance, and shipping groups.


Relationship Management: 
Partner with department heads to ensure coordination of purchasing, production, and shipping. Responsible for the smooth work flow process across these functional areas to ensure optimal performance and reduced errors.
Communicate with local community.
Network with Industry association counterparts

Product Development: 
Assure timely and efficient introduction of new and improved products, to ensure manufacturing input to product strategic plans.
Coordinates with R&D and Engineering groups to implement new products and equipment.
Communications & Working Relationships


Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Production, Manufacturing, Maintenance
Role Category: Head/VP/GM-Operations
Role: Head/VP/GM-Operations

Keyskills:
Plant OperationsVPPlant HeadFormulationscapsulestablets

Desired Profile:

Job Specification- 
  • B.Pharma/M.Pharma with 20-25 years of manufacturing experience in Formulation industry covering operations, maintenance, quality control and good manufacturing practices.
  • Must have 5-6 years of overall plant management experience with proven leadership record.
  • Plant management experience in a plant having more than 600 employees in last two jobs.
  • Experience of managing relations with government agencies.
  • Proven ability to direct and lead plant operations to drive production results. Independent, passionate in their work, customer focused and safety oriented. 

Education:UG -Graduation Not Required, Any Graduate - Any Specialization
PG - Post Graduation Not Required, Any Postgraduate - Any Specialization
Doctorate - Doctorate Not Required, Any Doctorate - Any Specialization

Company Profile:

Established in 1995 Ind-Swift has fast evolved towards a business model that is focused on deep-rooted domestic presence and leveraged on high-value mature regulated markets along with considerable growth in emerging markets:* Ind-Swift Laboratories Ltd. (Manufacturer of APIs)* Ind-Swift Laboratories Inc. (US Subsidiary)With manufacturing sites at 6 different locations across India and an independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. 

Contact Details
Recruiter Name:Akash Deep Sharma
Telephone:Not Mentioned
Email :Not Mentioned
Reference Id:ISL/GBU/P1
Website:



http://www.indswiftlabs.com/






Email :hr.gbu@indswiftlabs.com,sachin.sharma@indswiftlabs.com


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Quality Assurance - Reviewer Opening with Ind Swift Ltd, Dera Bassi Openings: 6

Image result for Swift Ltd, Derabassi

Job Description

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.

Desired Profile:


Education:UG -B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required

Company Profile:

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.

Contact Details:
Recruiter Name:Mr. Sachin Sharma
Contact Company:Ind Swift Laboratories Ltd
Telephone:91-172-522288
Email :hr.gbu@indswiftlabs.com,sachin.sharma@indswiftlabs.com
Address :Vill.Jawaharpur Teh.Derabassi Distt.Mohali, MOHALI,Punjab,India

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