Quality Assurance-Pharmacist

☞ GNH India Pharmaceutical Limited

看过: 111

更新日: 06-05-2024

位置: Mumbai Maharashtra

类别: 保健/医疗 家庭用品 药剂师/药剂师代表

行业:

薪水: ₹25,000 - ₹40,000 a month

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工作内容

Candidates pursuing further studies, please do not apply.

QUALIFICATION:
1. Graduation in B. Pharma, M.pharma.

2. Knowledge about GDP, SOP , QC , QA & Audit.

3. Schooling in English medium mandatory.

4. Mandatory to have Valid Pharmacy License and PPP.

5. Experience : 5-8 years of QA Pharmacist role

5. Age Limit : Up to 32 yrs.

6. Salary Offer : Gross CTC 25000/-to 40000/-pm

SKILLS :

1. Good command over English.

2. Quality Control.

3. Audit documentation.

4. Quality Assurance.

5. Internal Audit.

6. GDP, SOP, ISO 9001.

Job Description:

1. Preparation, Revision & Training of QA SOP’s:

  • Performed GAP analysis against QA SOP’s.
  • Preparation & Revision of QA SOP’s in Control Document Management System (CDM’S) as per requirement.
  • To conduct Training
  • room training of approved QA SOP’s to all concerned persons.

2. Audit & Inspection Readiness:

  • Preparation of Annual Internal Audits schedule.
  • Performing Internal Audits as per approved schedule.
  • Preparation of Internal Audits report.
  • Raised the CAPA’s in Track-wise system after agreement with stakeholders.
  • Verification of CAPA’s effectiveness
  • after predefined period.

3. Periodic Product Review:

  • Preparation of Periodic Product Review (PPR) of the products.

4. Preparation of Periodic Product Review (PPR) of the products.

  • To support contract manufacturing sites for validations during product transfer.

5. Process, Equipment, Facility & Utility Qualification:

  • To permed change control assessment validation / qualification perspectives.
  • Preparation and Maintenance of Site Validation Master Plan (SVMP).
  • Preparation of Monthly presentation on Site validation Steering Committee.
  • Tracking of monthly re qualification schedule.

Cleaning Validation:

  • Preparation of Cleaning Validation Protocols & Reports.
  • Performing Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) Study.

7. Quality Management Systems:
To carry out the gap analysis against Quality Management Systems.

  • Handling change controls , deviations and CAPA’s.
  • Carry out risk assessment in view of change in process / introduction of new product.
  • Raise and progress departmental change controls, deviations and CAPA’s.

Interested candidates are requested to come down for the interview with updated resume and passport size photograph any day between Monday to Friday from 11am to 3.30pm.

Address :

GNH India, Kamal Industrial Estate, G

Gala No.11, 1st floor, Kamat Industrial Estate , 396 Veer Savarkar Marg, Prabhadevi, Mumbai 400025.
Landmark : Opp Siddhi Vinayak temple , near Canada Bank.

Job Type: Full-time.

Job Type: Full-time

Salary: ₹25,000.00 - ₹40,000.00 per month

Experience:

  • Relevant: 5 years (Preferred)

Work Remotely:

  • No

Speak with the employer
+91 02262706900

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最后期限: 20-06-2024

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