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Assistant Manager/Sr Executive – Quality Assurance | Zydus Hospira Oncology | Ahmedabad | 5.00-9.00 L

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Zydus Hospira Oncology Private Limited (ZHOPL) is a 50-50 % joint venture (JV) company between Zydus Cadila Healthcare Limited (CHL), India, and Hospira Australia Pty. Ltd. A Pfizer Company.

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The company is the manufacturing base for a defined range of oncology (cancer treatment) formulations, namely cytotoxic injectable. ZHOPL has set up a manufacturing plant in Pharmez (SEZ), Pharma specific SEZ near Ahmedabad. The Company has secured regulatory approvals from global regulatory bodies like the USFDA, MHRA, Health Canada, TGA, ANVISA, and so on. This JV Company supplies injectable oncology formulations in the global generic market. ZHOPL has been rated AA-/Stable for the long term and A1+ for the short term by CRISIL.

Position: Assistant Manager/Sr Executive – Quality Assurance

Location: Ahmedabad, Gujarat, India

Job Description:

  • Complaint management
  • To log customer complaints received at the site and to investigate the root cause and assign appropriate CAPAs with respect to complaints received wherever applicable.
  • To co-ordinate with an external partner, vendor, and cross-functional team and closure of the complaint on time.
  • To prepare complaint trends as per site procedure.
  • To control and retention of Complaint related documents.
  • Change management (Permanent, Temporary, and emergency change controls)
  • Initiation of QA related change control
  • Review cross-functional change control
  • Investigation
  • To investigate and on-time closure of the deviation for the QA department
  • To review deviations from Production, warehouse and engineering department along with another department as and when required
  • To assign appropriate CAPAs against deviation initiated to avoid repetitive deviations
  • Active involvement in an investigation related to human error through PHP tool (irrespective of any department)

  • To initiate, draft, and assist in the approval of FARs related to the site.
  • FAR related activities:
  • To notify the Head Quality or designee,
  • Draft FARs
  • Comply comments on the FAR reviewed copy
  • Track FAR due dates and update
  • Trend analysis (Preparation and review)
  • Market action management (Recall)
  • Involvement and improvement in implementation and sustaining Electronic systems like E-BMR, SAP-PM, DMS
  • Handling of notification to management procedure, restriction of batches
  • To review/verify audit trail and alarms of the water system.
  • To audit & monitor the Gowning & Degowning, Cleaning, Sanitization, sterile material transport process, filling operation process. To provide coaching & feedback against the auditing point.
  • Part of the internal audit program
  • Involve in response to audit observation

Desired Skills:

QA, CAPA, Validation, PQ, OQ, BPR, Batch Release, APQR

Qualification: B.Pharma, M.Pharma

Experience: 5-6 Years

Salary: 5,00,000 to 9,00,000 INR CTC/PA

Contact Details:

Zydus Hospira Oncology Pvt. Ltd. (JV of Zydus & Hospira – a Pfizer company) Plot No. 3, Pharmez-SEZ, N.H. No. 8A, Matoda, Sanand, Dist.: Ahmedabad – 382 213

anita.mishra@zydushospira.com

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