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Open nowPosted 124 days ago

L 7 To L 6– QA (Validation/Qualification/IPQA/Lab QA)

SAVA HEALTHCARE38 open roles

Where
Pithampur
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Your applicationOpen nowL 7 To L 6– QA (Validation/Qualification/IPQA/Lab QA)SAVA HEALTHCARE · Pithampur

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12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 124 days ago

The posting

Job Title: Executive / Senior Executive – QA (Validation & Qualification)

Location: Indore Plant

Department: Quality Assurance (QA)

Reports to: QA Manager – Validation / Head QA

Role Summary:

We are looking for dedicated and experienced professionals to join our Quality Assurance (QA) Department as Executive / Senior Executive. The role involves supporting Validation & Qualification activities in any of the following areas:

  • Process Validation
  • Cleaning Validation
  • Facility & Equipment Qualification
  • Computer System Validation (CSV)

Candidates with hands-on experience in one or more of these areas are encouraged to apply.

Key Responsibilities (based on area of expertise):

Process Validation:

  • Prepare and review Process Validation Protocols and Reports (PV).
  • Coordinate validation batches with cross-functional teams.
  • Monitor critical process parameters and ensure adherence to approved specifications.
  • Perform risk assessments and gap analysis as required.

Cleaning Validation:

  • Develop and execute cleaning validation protocols and sampling plans.
  • Perform visual inspection and swab/rinse sampling for various equipment.
  • Review analytical data and calculate MACO/Residue Limits.
  • Maintain cleaning validation matrix and revalidation schedules.

Facility & Equipment Qualification:

  • Support IQ, OQ, PQ of equipment, systems, and utilities as per validation master plan.
  • Participate in installation, commissioning, and qualification activities.
  • Ensure periodic qualification and requalification as per schedule.
  • Maintain GMP-compliant records and reports for audits and inspections.

Computer System Validation (CSV):

  • Prepare and review URS, RA, IQ/OQ/PQ protocols for GxP systems.
  • Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles.
  • Coordinate with IT, QA, and software vendors during validation life cycle.
  • Maintain validation documentation and change control records.

Candidate Profile:

Qualification: B.Pharm / M.Pharm / M.Sc. (Life Sciences / Chemistry / Microbiology)

Experience: 2–6 years in regulated pharmaceutical / API / sterile manufacturing environments

  • Exposure to GMP, ICH, WHO, USFDA, and other regulatory guidelines is essential
  • Experience in one or more of the following: Process Validation, Cleaning Validation, Equipment Qualification, or CSV

Desired Skills:

  • Strong understanding of validation life cycle and risk-based approach
  • Good documentation and data review skills
  • Ability to coordinate with cross-functional teams (Production, QA, QC, Engineering, IT)
  • Audit readiness and familiarity with regulatory expectations
  • Proficiency in MS Office and documentation systems

Employment Type: Full-Time

CTC: As per industry norms and candidate’s experience

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