Easy Reach Placement, Established is a excellent brand equity with a premium image amongst HR community at many Indian Giants and Blue chip Multinational Conglomerates in catering manpower placement services for our valued patrons to manage their Human Assets. In the era of Hi-tech Millennium & Rapid Globalization with prevailing competition, sourcing of Right Candidate for the Right Job at Right Time at Right Cost. Easy reach is making significant Contribution in terms of meeting our Valued Clients quality manpower requirements ranging from Junior Level to Corporate Heads.
Post: Head QA for API
No.of post: 01
Job Description
1 Leading Direction and implementation of ISO 9001:2015,ISO14001:2001, FSSC22000/HACCP & cGMP requirements.
2 Identification and mitigation of Risks in area of operation.
3 Total responsibility of Quality Assurance functions.
4 Quality Planning and scheduling.
5 Implementation of company's Quality policy, QMS and GMP Regulations.
6 Document management and control.
7 Review, updating and implementation of quality system procedures as per cGMP.
8 Preparation, review, approval and implementation of QA SOPs.
9 Approval of quality documents.
10 Issue control on quality documents.
11 Retrieval, Retention and destruction of documents.
12 Review of product stability data.
13 Control on raw materials and packing materials.
14 Review and handling of out of specification results.
15 In-process control at all stages of manufacturing and packing.
16 Review of Batch process and testing documents.
17 Batch approval (or) rejection and release for dispatch.
18 Reviewing of certificate of Analysis.
19 Reviewing technical agreement and Quality agreement.
20 Change management and approval.
21 Deviation control and approval, handling of customer complaints.
22 Investigation of batch failure/rejection/OOS and necessary actions.
23 Handling of Product Recalls.
24 Annual product review for all products manufactured.
25 Handling of Vendor audits and approval.
26 Overall monitoring of quality activities as cGMP inspection in operating areas.
27 Handling of Internal audits.
28 Handling of Customer audits and regulatory audits.
29 Audit response and compliance for customer and regulatory audits.
30 Review and handling of corrective and preventive actions.
31 Handling of cGMP Training and documentation.
32 Training of Quality Systems procedures as a part of
Candidate Profile
Msc or Phd in chemistry
Additional Information:
Experience: 15-25 Years
Qualification: M.Sc, Ph.D
Location: Bangalore
Industry Type: Pharma/ Healthcare
Salary: 15 to 18 lakhs per annum
Job Type: QA
End Date: 5th Sept, 2016
Please email your cv on easyreachhr@gmail.com
Posted by,
Suvidnya Tendolkar,
Easy Reach Management Consultants
See All B.Sc Alerts B.Pharm Alerts D.Pharm Alerts M.Pharm Alerts
See All Other Jobs in our Database
.png)
