Executive QA - Amarnath, India - ASolution Pharmaceuticals Pvt. Ltd

Deepika Kaur

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Deepika Kaur

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Description

ONLY CANDIDATES THAT HAVE MINIMUM 4 YEARS OF WORK EXPERIENCE IN API MANUFACTURING SITE WILL BE CONSIDERED FOR THE ROLE.

Senior Officer / Executive / Senior Executive in Quality Assurance Department for IPQA, QMS, Audit and Compliance.

Qualification:
BSc/ BPharm /MSc /MPharm.


Experience: - 8 years


Salary: 4,00, ,00,000.00


Exposure to local GMP / Audit & Compliance / QMS Activity / Validations activity / Gap assessments / RCA / Risk Assessment / Vendor Qualifications / Equipment & Instrument Qualifications / Sampling / Analytical validation and other non-routine validation activities / Process Validation / Dispensing activities / Review Validation Master Plan / Deviation / Change Control / Analytical Quality Assurance / Cleaning Validation / APQR / Investigations / CMO activities / Regulatory & Non Regulatory Audit / Internal Audit / Local Audit / FDA audit / IPQA / BMR / BPR review / other key functions of QA and any other activity as designated by HOD.


Should be well versed with cGMP environment & current regulatory guidelines. Should have knowledge of ICH guidelines, audits by regulatory agencies such as WHO, US-FDA, EDQM/EU etc.

Salary:
₹400, ₹600,000.00 per year


Benefits:


  • Provident Fund

Schedule:

  • Day shift

Application Question(s):

  • How many total years of work experience do you have?
  • Are you currently working in Active Pharmaceutical Ingredient (API) manufacturing plant?
  • How many years of work experience do you have in API manufacturing plant?
  • Are you comfortable commuting to this job's location?
  • Do you have expertise in Audit & Compliance?
  • Do you have expertise in IPQA?
  • Do you have expertise in Quality Management System QMS?
  • How many years of work experience do you have using ICH guidelines?
  • If offered the role, Can you join within 15 days?
  • If offered the role, Can you join within 30 days?
  • Are you comfortable with the salary range stated in the advertisement?
  • Are you willing to work in rotational shifts if required?

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