Acme generics Vacancy | Quality Control Jobs

About Acme Generics:

Acme Formulation (a renowned name in the Indian Pharmaceutical industry in contract development and manufacturing pharmaceutical products) and SRS Pharmaceuticals (a leading export house based out of Mumbai and has a strong international presence in innovative drug products) entered into an alliance to create a world-class sterile facility to cater to global market consummating into the creation of Immacule Lifesciences Pvt. Ltd.

We identify, develop and register lyophilized and liquid injection formulations with the intent to offer our products under private labels to our partners all across the globe.

Our vision was to build a production plant that combines functionality and aesthetics with efficiency and safety in a harmonical ensemble. Maximum transparency and openness for customers and authorities, a bright, friendly and agreeable workplace for our employees and uncompromising pharmaceutical quality for the consumers were our mission statements for this plant.

Here, people work for people, our employees create values for customers and consumers committed to Immacule’s motto “Focusing on people”.

Space and Light and Order. Those are things that men need just as much as they need bread or a place to sleep” quote from the famous French Architect Le Corbusier who designed the city of Chandigarh which is 60 km from the facility, has served as inspiration for defining the architecture of Immacule.

The result is a sterile production plant that is perfect in functionality, efficiency and flexibility. Committed to the guiding principle of “value for customers” Immacule’s project team made sure that from the first draft of the building, up to the initial operation, a plant layout was created that combines reliable product quality, pharmaceutical safety and efficient manufacturing with anticipatory development planning and flexible order processing.

Now it is possible to manufacture development batches of 10 litres as well as manufacturing campaigns with up to 500 litres of scheduled quantity. This applies both to terminal sterilized and aseptically manufactured products. Future regulatory requirements have been anticipated and taken into account during the planning of the new sterile production plant. Based on theoretical simulations the layout of the plant has been engineered for optimum workflow.

Using integrated pass-through and hatches in the new sterile production plant, materials can always be moved from one production stage to the next via the shortest route. The material follows the most efficient route, and the personnel the safest one. All movements of materials and personnel within the sterile facility are minimized and organized in such a way that contaminations of the end product are eliminated from the outset.

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About Acme Generics Jobs:

We at Acme Generics, hiring for Head – Quality Control with below Job Specification and description.

Job Title : DGM & Head Quality Control
Experience: 15-20 Years
Qualification: M.Sc., B. pharma, M. pharma
Location: BADDI.

Note: Candidate should be working in USFDA Approved facility.

Role and Responsibilities.

Following will be the responsibilities of position holder:

Roles and Responsibilities

1. To manage QMS activity like change control, Deviation, CAPA, OOS, OOT, Lab events etc.
2. To Conduct Risk Assessment& SOP reviews; investigating& supporting in the grievances.
3. Responsible for Document & review Specification, SOPs, Review of Test Data Sheet, Analytical Test Report & Masters.
4. Responsible for review of Method Validation Protocols & Method Validation Reports.
5. To Monitor the Review of calibration/Preventive maintenance schedule.
6. Responsibilities to Initiate for Procurement of impurity standard/reference standard, chemicals/reagents, columns, Laboratory glasswares etc.
7. To Develop and implement Site Policies & Procedures (SOPs) to assure compliance with regulatory requirements, and corporate policies
8. Responsibilities to Supervising deviation review and managing the CAPA review, approval and implementation reviews
9. To Create goals, objectives and measures to drive continuous improvement of the QC operations
10. Responsible for implementing the CAPA Parameters after investigation.
11. Responsibilities assign to check the effectiveness of CAPA.
12. To ensure Co-ordination for IQ, OQ, PQ and qualification plan of the instruments.
13. Responsible for Coordinate & present all relevant documents to external auditors and to ensure that corrective measures are taken on any non-compliance finding.
14. To Review method transfer protocols & reports & stability protocols.
15. Responsible for rendering technical support to the Section in charges and managers.
16. To Review various submissions to General Export and other regulatory markets related to quality control.
17. Responsible for Review of comparison protocol & report of multimedia DRP & Dose dumping between RLD & exhibit batches.
18. To complete quality projects within time by proper planning & execution of planning.
19. To ensure the Implementation of several measures to identify deformities, malfunctions or other abnormalities such as Periodic verification of instruments/Equipment / components / products, Trending of failures.
20. To Coordinate with various cross functional groups for timely availability of API/RM, PM , manufacturing area (Production), Analytical documents (Like Method Transfer, Specifications, Analytical Testing procedures etc.) & Quality control facility (Like column, critical chemicals working standard & impurities). Interested candidates can shared their updated resume at career@acmeformulation.com

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