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5 Althera Laboratories India Jobs

Manager - Cleaning Validation (OSD), Mysore

14-16 years

Mysuru / Mysore

2 vacancies

Manager - Cleaning Validation (OSD), Mysore

Althera Laboratories India

posted 1d ago

Job Role Insights

Flexible timing

Job Description

Role & responsibilities:

  • To handle cleaning validation activities. (MACO calculation, product and equipment matrix preparation, grouping, sampling location/ analytical method updating in software as well as manually.
  • Preparation of cleaning validation, cleaning verification, cleaning study protocols and report compilation. Evaluation of newly introduced equipment/product with respect to cleaning validation master plan (Bracketing) for cleaning validation and cleaning verification requirements.
  • Various cleaning study execution with respect to change in cleaning agent/cleaning procedure.
  • Annual Cleaning process review report preparation for evaluation of cleaning process/ Change Control/ Deviation/ New product introduction/ New equipment introduction not limited to.
  • Protocol preparation, execution and report compilation of DEHT/CEHT/recovery study for various equipment and to evaluate gap assessment in cleaning validation SOP.
  • To support Process validation and Hold time study activities
  • Execution in duct cleaning validation/ verification activities with CFT
  • Identification of Hard to clean locations of equipment with production team.
  • Identification of worst case products and calculation of swab limits.
  • Determination of Visual residue limit by protocol based study.

To involve in investigations / failures related to cleaning methodologies.


Preferred candidate profile:

  • Well-versed with Cleaning Validation activities in OSD mfg. site.
  • Sharp in Documentation and Review of shopfloor data
  • Good communication and interpersonal skills
  • EU/ TGA/ ANVISA regulatory audit exposure is an advantage
  • Good knowledge of European agency guidelines
  • Sound knowledge of ALCOA+ concepts and able to identify gaps w.r.t. ALCOA+ principles if any at shopfloor operations.
  • Strong analytical and problem-solving skills
  • Attention to detail and ability to work under pressure
  • Knowledge of the local language (Kannada) is an added advantage

Perks and benefits:

Best in industry


Employment Type: Full Time, Permanent

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Manager salary at Althera Laboratories India

reported by 3 employees with 9-12 years exp.
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₹13.1 L/yr - ₹16.4 L/yr
10% less than the average Manager Salary in India
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What Althera Laboratories India employees are saying about work life

based on 14 employees
56%
75%
38%
100%
Flexible timing
Alternate Saturday off
Within city
Day Shift
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Althera Laboratories India Benefits

Free Transport
Child care
Gymnasium
Cafeteria
Work From Home
Free Food +6 more
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