Job Description:
PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position’s major responsibilities or end results

Operational Performance Analysis

  • Conduct ICSR quality reviews per agreed procedures, under supervision/mentorship of Sr OP Analyst/OP Scientist as appropriate.
  • Development and production of operational performance metrics/dashboard for compliance, quality, productivity and cost-per-case for onshore, offshore and ad hoc vendor partners, as necessary.
  • Participation in functional and cross-functional project teams and meetings relating to operational performance analysis.
Other
  • Participate in internal audits and external inspections as identified in relation to CPM activities
  • Assist in development & implementation of corrective/preventive action plans (CAPAs) as identified
  • Participate in local or global project teams, including on-time delivery of assigned responsibilities
  • Perform other related duties as required
  • Maintain compliance with HR and other business policies and guidelines
  • Personal development: continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development

Key Attributes/GLPs
Integrity & credo-based actions(GLP)
Results & performance driven (GLP)
Big picture orientation with attention to detail (GLP)
Collaboration & teaming (GLP)

Candidate Profile :
Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science

Pharma Experience:

  • Minimum 4 years of overall work experience in the functional area with at least 2 years experience in Peer review or Quality review.
  • Experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports, preferred.
  • Required skills, abilities and competencies include:
  • Understanding of medical terminology preferred
  • Ability to follow guidelines and procedural documents (experience of working with SOPs, etc. preferred)
  • Oriented to quality, attention to detail necessary

Manages own work:

  • ability to prioritize, plan and organize work assignments, and able to work under strict timelines
  • Ability to effectively delegate work responsibilities to others
  • Ability to work both independently and in collaboration with others
  • Proactive approach/uses own initiative appropriately
  • Decision-making and problem solving skills
  •  Flexibility and adaptability

Other skills:
Good verbal and written communication skills
Excellent computer skills (Word, email, PowerPoint) preferred, and especially in Excel (or Access)
Familiarity with safety systems preferred

Additional Information:
Experience: 4 years
Qualification: M.Pharm/B.Pharm
Location: Mumbai
Department: Pharma
Job Function: Regulatory Compliance
Requisition ID: 1600126449W

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