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Executive, QA

3 weeks ago


Bengaluru, India Apotex Research Private Limited Full time

**About Apotex Inc.**

**Job Summary**:
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.

**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 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.

**Job Requirements**:

- Education
- Minimum Bachelor Degree holder in Science or Pharmacy.
- Knowledge, Skills and Abilities
- Knowledge about GCP/GLP guidelines, Regulatory requirements, best practices and established safety standards.
- Knowledge in writing in Standard Operating Procedures, preparation of QA audit reports of the audits and do necessary follow ups whenever required.
- Job requires being reliable, responsible, and dependable, and fulfilling obligations.
- Job requires analyzing information and using logic to address work-related issues and problems.
- Job requires a willingness to take on responsibilities and challenges.
- Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
- Job requires ability to Active listening, Problem solving and Time management.
- Experience
- Minimum 2-4 years Experience in Regulated Industry.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.