QA Manager For pharma industry at location Dombivli

4 days ago

Mumbai, India Job Search Full time

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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