Senior Officer, QA (BEC)

Responsible for monitoring, auditing and assuring the quality of operational aspects of the Facility according to established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements with support of auditors & other senior members.

• Ensures that assigned work is performed in accordance with GCP, GLP, SOPs, regulatory requirements, best practices and established safety standards as applicable.
• Performs audits (both project and non-project related) to assure the compliance to GCP/ GLP, SOPs, regulatory requirements of the following departments wherever applicable; Bio analytical Operations, Clinical Operations Department, Pharmacokinetic Unit, Quality Assurance Unit, and Other general divisional operations.
• Conducts in process surveillance (both project and non-project related) to assure ongoing compliance of the Bio analytical Operations/Clinical Operations/others Department as applicable.
• Prepares QA audit reports for all the above audits/surveillances performed.
• Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
• Performs audit / review of software validation packages and IQ/OQ documents for systems used within the facility.
• Assists in the formal training of new and existing QA staff members to both QA and facility audit and procedures.
• Revise, implements, and maintains records of standards Operating procedures and additional relevant documents for the facility.
• Assists in Internal Audits whenever required.
• Reports to QA Management with respect to the operational status and disposition of all matters relating to the operations in the QA unit.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

• Education
  • Minimum Bachelor Degree holder in Science or Pharmacy.
• Knowledge, Skills and Abilities
  • Knowledgle on current Guidelines like ICH Guidlines ,GCP and GLP for BA/BE studies
  • Technical skills on LIMS, EP and Analyst software.
  • Ability to perform audits in accordance to GDP, GLP and GCP and other requlatory requirements.

• Experience
  • Minimum 2-4 years Experience in Regulated Industry.