Quality Assurance Jobs at Apotex | Apply Now for Pharma Jobs in Bangalore
Are you currently seeking rewarding Quality Assurance Jobs that allow you to make a global impact? Apotex is hiring a Senior Officer for our team, offering one of the most premier Pharma Jobs in Bangalore. This role is perfect for a dedicated professional ready to ensure excellence in GCP and GLP standards while working with a Canadian-based global health leader.
- Job Title: Senior Officer- Quality Assurance
- Location: Bangalore, KA, IN, 560099
About the Company
Apotex is a Canadian-based global health company. They improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico, and India, they are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
Job Description
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.
Key Responsibilities
- 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 ensure compliance with 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 ensure ongoing compliance of the Bioanalytical Operations/Clinical Operations/others Department as applicable.
- Prepares QA audit reports for all the above audits/surveillances performed.
- Conducts appropriate follow-up and takes 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 in both QA and facility audit and procedures.
- Revise, implement, and maintain records of Standard 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, 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.
Qualification
Education
- Minimum Bachelor’s Degree holder in Science or Pharmacy.
Knowledge, Skills, and Abilities
- Knowledge of current Guidelines like ICH Guidelines, GCP, and GLP for BA/BE studies.
- Technical skills in LIMS, EP, and Analyst software.
- Ability to perform audits in accordance with GDP, GLP, GCP, and other regulatory requirements.
Experience
- Minimum 2-4 years of experience in the regulated industry.
