Dy. Manager/ Manager - Audit & Compliance - OSD Manufacturing Expert

  • Hyderabad
  • Confidential
  • 10-12 years
  • 19 May 2015

  • Audit and Assurance, Compliance/ Regulatory

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Key Responsibilities:

Plan and perform audits as per the audit schedule, compile final audit report after collating the same from different team members and share with the site-teams.
Ensure the compliance to the regulatory audit observations;
Ensure the compliance to internal standards;
Conduct follow-up audits to ensure compliance of audit observations, in order to adhere to the schedule, and to ensure anytime audit readiness.
To perform pre-audits prior to regulatory audit. Support the unit teams / QA teams in regulatory audits with facilities & documentation based on the need in order to ensure smooth handling of external audits.
Perform analysis on audit observations and to share summary to the Head Audit and Compliance to draw conclusions on training needs. The leanings to be shared across the internal sites in order to build unit/bushiness level capability in terms of compliance & audit preparedness.

Technical Requirements:

GMP & Regulatory guidelines, basic knowledge of equipment/machines, updates in the pharma industry,latest trends of the industry.

Key Personal Attributes

Highly energetic with good learning ability and execution skills
Good communication skills and Analytical thinking skills
Networking & influencing,
Collaboration & team work, negotiation,
Understanding the trouble shooting

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