Aurobindo Pharma Limited, a leading pharmaceutical company, is seeking a highly motivated and experienced QA Executive to join our dynamic Formulation Division team in Naidupeta, Andhra Pradesh. This is an exceptional opportunity to contribute to the production of high-quality pharmaceutical products and advance your career within a reputable global organization. Are you a detail-oriented professional with a passion for quality and compliance? Then this could be the perfect role for you.
A Rewarding Role in Quality Assurance
This position, QA – Validation, QMS, Market Complaints, offers a diverse and challenging role within our Formulation Division. You will play a vital part in ensuring the consistent quality and regulatory compliance of our products. This involves a range of responsibilities, including but not limited to:
- Regulatory and Customer Audit Coordination: You will be instrumental in coordinating internal and external audits, ensuring seamless cooperation and addressing any identified gaps proactively. This includes preparation, execution, and follow-up actions, showcasing your strong communication and organizational skills.
- CAPA (Corrective and Preventive Action) Review and Implementation: A critical aspect of this role involves the thorough review and efficient implementation of CAPAs. You will play a key role in identifying root causes, developing effective corrective actions, and ensuring preventive measures are put in place to avoid future occurrences. This requires analytical thinking, problem-solving skills, and a commitment to continuous improvement.
- Product Quality Review (PQR) Knowledge and Application: You will utilize your in-depth understanding of PQR processes to critically evaluate product quality data, ensuring compliance with regulatory guidelines and internal standards. This requires a keen eye for detail, a strong understanding of GMP (Good Manufacturing Practices), and the ability to interpret complex data sets.
- Critical Process Parameter (CPP) and Critical Quality Attribute (CQA) Data Approval: You will be responsible for the review and approval of CPP and CQA data, ensuring the data integrity and adherence to established quality standards. This demands a comprehensive understanding of pharmaceutical manufacturing processes and a rigorous approach to data validation.
- Market Complaint Handling: You will be involved in the process of investigating and resolving market complaints, ensuring timely and effective responses to customer issues while maintaining compliance with regulatory requirements. This requires strong analytical skills, problem-solving abilities and excellent communication skills.
This position demands a proactive individual who can work independently and collaboratively within a team environment. You will be a key player in maintaining our high standards of quality and compliance.
Ideal Candidate Profile: Skills and Experience
To excel in this role, you should possess the following qualifications and experience:
- Education: B Pharmacy, M pharmacy, MSc
- Experience: 2-7 years of relevant experience in the pharmaceutical formulation domain is essential. Candidates with experience in a regulated environment are highly preferred.
- Key Requirements: A strong background in pharmaceutical formulation is crucial. Proven experience in any of the following areas is highly desirable: Validation activities, Quality Management Systems (QMS), GMP (Good Manufacturing Practices), and regulatory compliance. Excellent knowledge of regulatory requirements, ideally including experience with audits from relevant agencies, is a significant advantage.
- Technical Skills: Proficiency in data analysis and interpretation is necessary. Experience with relevant software and quality management systems will be advantageous.
- Soft Skills: Strong communication, both written and verbal, is essential. Exceptional organizational skills, problem-solving abilities, and a detail-oriented approach are vital for success in this role. The ability to work effectively both independently and as part of a team is also crucial.
Location and Application Process
The position is based at Aurobindo Pharma Limited, Unit IV, SEZ Menakur, Naidupeta, Tirupati District, Andhra Pradesh – 524421.
To Apply:
Interested and qualified candidates are encouraged to submit their updated CV to naidupetahr@aurobindo.com. Please use the subject line: “QA Executive Application – Formulation Division“. A compelling cover letter highlighting your relevant experience and explaining why you are the ideal candidate for this role is highly recommended. We look forward to receiving your application and exploring how you can contribute to the continued success of Aurobindo Pharma.
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