Quality Assurance Executive
20 hours ago
Company Description:
Sun Pharma is a leading global speciality generic pharmaceutical company, ranked as the fourth-largest worldwide and No. 1 in India. We offer high-quality, affordable medicines trusted by customers and patients in over 100 countries. With a global presence supported by numerous manufacturing facilities and R&D centres, Sun Pharma fosters excellence through innovation, boasting a diverse and multicultural workforce.
Role Description:
This is a full-time on-site role as a Quality Assurance Executive at Sun Pharma's location in Bengaluru. The Quality Assurance Executive will be responsible for performing quality control, management, auditing, and ensuring adherence to quality standards in the pharmaceutical analytical process on-site.
Experience
:
A minimum of 4-6 years in Vaccines / Blood products / Biosimilars / Small
molecules with Good process/Analytical understanding, Quality / Regulatory
concepts.
Qualifications:
- Bachelor's / Master degree in Biochemistry, Bio-Technology, or other Life Sciences.
- Quality Control and Quality Assurance skills
- Experience in Quality Management and Auditing.
**Detailed Job Description:
Responsible for review of analytical records, handling of EDAMS, LMS, QMS /EDMS
related activities for Quality Assurance, Quality control, Internal Audit observations and
compliance for Quality Control.
GMP/GLP rounds as part of periodic Lab and routine facility maintenance / assurance on EM
/ Water monitoring in order to ensure the product SISPQ (Safety, Identity, Strength, Purity &
Quality) while batch review / release through a proper tracking mechanism in place.
Review of process technical / regulatory documents, coordinating with SMEs and assisting to the HOD.
Strong attention to detail and analytical skills
Excellent communication and problem-solving abilities.
Quality assurance certifications are a plus.
To have understanding and managing the Training related activities of Onboarding, On-Job and other modes to maintain the Lab, other applicable areas against Job roles. Tracking and reporting any abnormalities, escalating to hierarchy to comply as per the SOP/s.
Skills/Competencies:**
- The candidate should have understanding / knowledge on Analytical
technology of Biological products and basics of Biotechnology, various
Pharmacopeia (IP, BP, Phr. Eur. ), Guidance For Industry, ICH, WHO and their
requirements in Raw material, Primary Packing Material, Intermediates &
Finished Products.
- Should have good writing / reading / speaking skills for effective
communication, collaboration and for deliverables.
- Computer literacy, Computer system Validation (QC lab and Process Control
systems) concepts and automation systems handling including any
Quality/statutory certifications of ISO/QMS is added advantage.
- Understanding on User Access, Inventory Management, GxP Computer
generated data Audit Trail, retrieval, Backup and restore management.
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