|Number Of Vacancy||01|
|Industry Area||API pharma|
|Key Skills||QA, review, samling, approving , SOP|
|Qualification||M.SC, M.pharm & Ph.D|
|Salary (Per Annum)||7 Lacs|
|Work Experience||3 to 7 yrs|
1. QA batch release of manufactured ‘specials’.
2. Reviewing and approving new formulations, labels, shelf life extensions, repacks and in-house preparations.
3. Writing, reviewing and approving Quality documentation, including validation protocols and reports, change controls and Good Manufacturing Practice (GMP) deviations
4. Assisting with customer and product queries and complaints. Writing, reviewing and approving Standard Operating Procedures (SOPs).
5. Involvement with technical customer queries and product investigations. Responding to enquiries in a timely manner, giving advice on ‘specials’ quality requirements in order to maintain the company's reputation for customer service and technical acumen.
6. Dealing with the administration and monitoring of the QMS, including change controls, GMP deviations, technical agreements, validation reports, quality risk assessments, customer complaints, periodic reviews, self inspection and external audit reports, and SOPs
7. Conducting/assisting with internal self-inspection audits.
8. Participating in regulatory inspections
9. Ensuring that the business complies with current and future worldwide GMP standards and requirements.
10. Carrying out monthly review of Controlled Drug (CD) stock checks.
11. Dealing with CD related activities on site and advising the company’s Regulatory Manager of any issues with CDs.
12. Delivering internal training e.g. GMP and Hygiene Induction training, Level 3 Diploma in Pharmacy Service Skills (NVQ).
13. Ensuring safe working practices in accordance with COSHH. Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
14. Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
15. Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
16. Observing and complying with company Health and Safety Policies.
17. Observing and complying with company Standard Operating Procedures (SOPs)
18. Drafting, reviewing and authorization of standard test procedures (STPs), validation protocol, validation reports, analytical reports and Certificated of analysis ( COAs).
|Job State / U.T.||Gujarat|
|Company Name||Our client|
Established in 2011, as a private limited company registered under Companies Act, 1956, we are quickly growing towards creating a vast impact on the healthcare industry. We are set with cutting-edge infrastructure which allows us to effect our products’ quality, safety and efficacy. These attributes are the basis of our commitment to patients, and of our abiding efforts to making the difference. Our product offerings deliver at realistic prices in regulated markets around the world.
It is presently engaged in more than 30 API development projects and plans are underway to work on NCE's in the near future. We offer more than 20 generic drug substances for a variety of health issues including oncology, anti-diabetic, and antimicrobials. We have the ability to manufacture peptide API's from gram to kilogram scale and small molecules from gram scale to tons. Our proficiency in API manufacturing will assist us further augment our in-house product array and also the size and assortment of our contract manufacturing business sector.
It has spread in 10000 sq ft built up state of the art R&D facility and which comprises three dedicated labs for chemical development and two labs each for analytical development and formulation activities
|Contact Person||Ms. Sonal Kharwa|
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