
QA Manager For pharma industry at location Dombivli
3 days ago
Urgent opening for the profile of QA Manager for pharma industry at location Dombivli.
Experience: Min 5 years (must have experience in API).
Qualification: M.Sc.
Department Quality Assurance
Designation Asst. Manager QA
Reporting to Vice President / Head QA
Description of Job Responsibilities
* Responsible for Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA.
* Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc.
* Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees.
* Responsible for preparation and review and updation of Drug master file and handling of regulatory queries.
* To evaluate quality and stability of finished APIs.
* Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures.
* To investigate Out of Specification cases
* Responsible for review of MSDS and approval
* Responsible for preparation of annual product quality review.
* Responsible for providing effective CAPA procedures, tracking completion and implementation of the same.
* Responsible for validation activities as per validation master plan.
* Responsible to investigate customer complaints and provide responses to customers regarding complaints.
* Ensure effectiveness and continuous improvement of the QMS System.
* Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions
* To organize vendor audits for critical raw materials.
* Responsible for market queries and market related documents submission
* Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions
* Responsible for updating and maintaining quality management system documents.
* Responsible for regulatory affairs and other customer and regulatory queries.
* Responsible for preparation and review of product quality review.
* To organize and participate in MRMs and to monitor actions of the same.
* Responsible for review of Intermediates - API & approval/rejection / release batches in absence of Vice President/ Head QA.
* To organize vendor audits for critical raw materials.
* Responsible for maintaining and handling of vendor qualification activities
If you are interested for the above referred position, kindly revert back with your Updated Resume along with following details:
1) Current salary
2) Expected salary
3) Notice period
4) Total experience
5) Relevant experience
6) Current resident location
7) Reason for job change
Contact on Whatsapp number
E-mail Id:
Contact Person: Sakshi
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