Job Title: Quality Assurance Officer HLL-III
Location: Nakkapally, Anakapali, Andhra Pradesh, India
Department: Quality Assurance
Job Posted On: Feb 14, 2025
Employee Type: Outsourcing
Experience Range: Not Applicable (Entry-level position)
Key Responsibilities:
1. Documentation and Compliance:
Review batch manufacturing records (BMR) and batch packing records (BPR) for completeness, accuracy, and compliance with Good Manufacturing Practices (GMP).
Prepare, review, and approve standard operating procedures (SOPs), work instructions, and specifications to ensure adherence to organizational and regulatory guidelines.
Ensure compliance with pharmacopeial standards (USP, BP, IP, EP) and regulatory requirements such as FDA, WHO, and ICH guidelines.
2. Batch Release:
Evaluate and approve batch documentation for the release of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs) in accordance with GMP and quality standards.
Ensure that all deviations, change controls, and out-of-specification (OOS) results are appropriately addressed before batch release.
3. Audits and Inspections:
Participate in internal audits, vendor audits, and regulatory inspections to ensure adherence to quality systems and regulatory standards.
Assist in preparing corrective and preventive actions (CAPA) based on audit findings and ensure timely implementation.
Maintain audit readiness and work to ensure compliance with all relevant regulatory requirements.
4. Change Control and Deviations:
Manage the change control process for materials, processes, and equipment to ensure all changes are well-documented and meet regulatory standards.
Investigate deviations and non-conformances, identify root causes, and implement CAPAs to prevent recurrence and ensure continuous quality improvement.
5. Validation and Qualification:
Support various validation activities including process validation, cleaning validation, and analytical method validation to ensure that all systems and processes meet the required standards.
Ensure that all equipment and systems are qualified (IQ, OQ, PQ) as per established protocols and regulatory requirements.
6. Training and Awareness:
Provide training to production, QC, and QA teams on GMP, quality systems, and SOPs to ensure everyone follows proper procedures.
Promote a culture of quality and continuous improvement within the organization, encouraging collaboration and adherence to best practices.
7. Quality Systems Maintenance:
Maintain and monitor quality systems such as deviation management, CAPA, and change control to ensure consistency and compliance.
Conduct periodic quality reviews and ensure timely updates and reviews of all quality-related documents.
8. Stability Studies and Risk Management:
Monitor stability studies for APIs and ensure compliance with ICH guidelines to predict shelf life and optimize storage conditions.
Conduct risk assessments for processes, materials, and equipment to ensure product quality and safety.
Qualifications and Skills:
Education:
Master’s degree in Chemistry or B. Pharmacy is required.
Technical Skills:
Strong knowledge of GMP, GLP, and relevant regulatory guidelines (FDA, WHO, ICH).
Familiarity with quality systems such as deviation management, CAPA, and document control to manage compliance.
Understanding of process validation, equipment qualification, and analytical method validation is essential for the role.
Soft Skills:
Attention to detail and organizational skills to ensure accurate documentation and compliance.
Strong communication and documentation abilities for effective coordination across teams.
A problem-solving mindset with the ability to collaborate across departments and resolve issues swiftly.
Work Environment:
This role is office and manufacturing site-based, with occasional exposure to production environments.
The position may require flexible working hours to meet production or audit schedules.
Key Performance Indicators (KPIs):
Timeliness and accuracy in reviewing and approving documentation, ensuring batches are released on time.
Compliance with GMP and regulatory requirements during internal audits, vendor audits, and regulatory inspections.
Effective resolution of deviations and the implementation of CAPA to prevent recurring quality issues.
Effectiveness of training and adherence to SOPs by all team members.
Summary:
The Quality Assurance Officer role at HLL-III provides an excellent opportunity for an individual to contribute to the quality and compliance aspect of pharmaceutical production. This position offers experience in batch release, documentation, auditing, change control, validation, and ensuring adherence to GMP and other regulatory standards. The role requires attention to detail, strong problem-solving abilities, and excellent organizational skills to ensure smooth operations within the quality assurance function.
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