Titan Laboratories Pvt. Ltd., a leading pharmaceutical company, is seeking a highly motivated and detail-oriented QA Officer – Executive – Documentation & IPQA to join our growing team in Mahad. This crucial role offers a fantastic opportunity to contribute significantly to the quality and compliance of our pharmaceutical products. If you’re passionate about maintaining the highest standards in a dynamic and rewarding environment, we encourage you to apply.
About Titan Laboratories Pvt. Ltd.
Titan Laboratories Pvt. Ltd. is a prominent player in the pharmaceutical industry, committed to delivering high-quality medications that improve lives. We pride ourselves on our unwavering commitment to cGMP (Current Good Manufacturing Practices) and GLP (Good Laboratory Practices), ensuring the safety and efficacy of all our products. We foster a culture of collaboration, innovation, and continuous improvement, providing a supportive environment for professional growth and development.
Job Description: QA Officer – Executive – Documentation & IPQA
This multifaceted role within our Quality Assurance – Documentation department in Mahad offers a blend of responsibilities vital to maintaining our exceptional quality standards. Your contributions will directly impact the accuracy and integrity of our documentation and manufacturing processes.
Key Responsibilities:
- In-Process Quality Assurance (IPQA): Actively participate in IPQA activities across manufacturing and packaging areas, ensuring adherence to established procedures and standards. This includes real-time monitoring and intervention to prevent deviations from specifications.
- Documentation Management: Maintain meticulous records of qualification and calibration activities, ensuring complete and accurate documentation for all equipment and processes. This involves the creation, review, and archiving of essential quality documentation.
- Deviation Investigation: Conduct thorough investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results, following established protocols and identifying root causes to prevent recurrence. This requires strong analytical and problem-solving skills.
- Stability Program Management: Manage and document the stability studies for various pharmaceutical products, ensuring compliance with regulatory guidelines and interpreting stability data accurately.
- Audit and Inspection Support: Provide comprehensive support during internal and external audits, and regulatory inspections. This involves compiling necessary documentation and responding to auditor/inspector queries effectively.
- Regulatory Compliance: Maintain a strong understanding of cGMP and GLP guidelines, and other relevant regulatory requirements (ICH, WHO, etc.) Ensure all activities are conducted in full compliance with these regulations.
- Continuous Improvement: Actively participate in process improvement initiatives and contribute to the ongoing development and enhancement of QA systems and procedures.
Candidate Profile:
To excel in this role, you should possess the following qualifications and attributes:
- Education: B.Pharm, M.Pharm, or M.Sc in a relevant scientific discipline.
- Experience: 2-4 years of hands-on experience in Analytical QA within the pharmaceutical industry. Experience with IPQA activities is highly desirable.
- Regulatory Knowledge: A strong understanding of regulatory requirements, including ICH, WHO, and other relevant guidelines, is essential.
- Documentation Expertise: Exceptional documentation practices are crucial; you must be meticulous and detail-oriented. Proficiency in maintaining accurate and complete records is paramount.
- Audit Readiness: Demonstrated experience in supporting audits and inspections, with a proactive approach to ensuring compliance.
- Analytical Skills: Ability to analyze data, identify trends, and solve problems effectively.
- Communication Skills: Excellent written and verbal communication skills are necessary for effective collaboration and clear documentation.
Why Choose Titan Laboratories?
- Career Growth: We offer opportunities for professional development and advancement within a rapidly growing organization.
- Competitive Compensation: We provide a competitive salary and benefits package.
- Supportive Environment: We foster a positive and collaborative work environment where your contributions are valued.
- Meaningful Work: You will have a direct impact on the quality and safety of pharmaceutical products that improve lives.
Ready to Make a Difference?
If you meet the qualifications outlined above and are ready to embark on a challenging and rewarding career in the pharmaceutical industry, we encourage you to apply. Please submit your CV to shweta.m@tiapharma. We look forward to hearing from you.
