Gland Pharma Ltd. A globally-renowned manufacturer of Small Volume Parenterals (SVPs), Gland Pharma was founded in 1978 at Hyderabad by a visionary, PVN Raju, who has always thought far ahead of his time.

Since its inception, Gland Pharma stands testimony to the founder’s exemplary commitment to Quality, has emerged as a global player with a presence in about 90 countries in five continents. We have a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, and ophthalmic solutions. We enjoy the distinction of having pioneered Heparin technology in India and are world leaders in the Glycosaminoglycans (GAGs) range of molecules.

Walk-in-Interview/SKYPE of Shortlisted Candidates

Department: QA Validations

Job Description:

VALIDATIONS:

  • Hands-on experience in qualifications and validations of equipment like Autoclaves, Lyophilizers, Isolators, Vial/Ampoule washing machine, Tunnel sterilizer, Vial/PFS filling machine, vial, and ampoule sealing machine, Terminal sterilization autoclave qualifications, Filling and Mixing vessels and Glove leak test studies.
  • Hands-on experience in qualifications and validations of HVAC/Clean rooms and smoke flow studies/Airflow visualization studies.
  • Hands-on experience in qualifications and validations of utility gas qualifications like Compressed air, Nitrogen, and Carbon dioxide.
  • Hands-on experience in qualifications and validations like Temperature mapping for area and equipment Like Refrigerators, Incubators, Walk-in coolers, Deep freezers, Stability chambers, Cold chambers, Hot air oven, Dry heat sterilizers.
  • Hands-on experience in qualifications and validations like Pharmaceutical water system (All phases of Purified water, WFI and pure steam and steam quality tests)
  • Hands-on experience in qualifications and validations like packing related optical inspection machine (Make: Brevetti), Vial/ampoule labeling machine, Blister packing machine, shrink wrapping machine, qualifications of packing lines Track and trace systems (serialization and aggregation).

  • Preparation, compilation, and report preparation of qualification and validation protocols. (From URS to PQ and RQ)
  • Preparation, Scheduling, and follow-up of monthly qualification and Requalification activities as per the Validation master plan.
  • Active participation in Regulatory, customer Audits/Inspections and Knowledge on regulations and guidelines like USFDAISOPDAHTMEMEAPICSISPE, and Schedule-M, etc., on above-mentioned activities.

CALIBRATIONS:

Hands-on experience in all the above-mentioned equipment and instruments (Like Lyophilizers, Autoclaves, Tunnel, Mixing and filling vessels, etc.,) Calibration activities.

Flexible to work in shift activities in the above respective areas.

Qualification: B.Sc/M.Sc/B.Pharmacy/M.Pharmacy

Experience: 1-4 Years

Job Location: Gland Pharma Ltd, Pashamylaram, Patancheru, Telangana

Contact Details:

Please Mail your resume with Subject Line “QA Validation” to

admin.pmy@glandpharma.com, hanumanthrao.rasike@glandpharma.com

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