Injectable Plant Compliance Manager

Greetings from Hetero Labs Limited.!!

We have an urgent opening for the formulation Unit VI (Injectable) @ Jadcherla, Mahabubnagar.

Job Title:

Location

Company:

Job Type

Reporting too

Qualification:

Experience:

Strong knowledge of regulatory requirements for injectable pharmaceuticals (FDA, EMA, etc.).

We are seeking a motivated and detail-oriented Injectable Plant Compliance Manager to join our team. The ideal candidate will be responsible for ensuring compliance with all regulatory requirements and industry standards specific to the production of injectable pharmaceutical products. This role will serve as a key leader in maintaining quality assurance, overseeing audits, and implementing compliance systems to ensure the safety and efficacy of our products.

Key Responsibilities:

Regulatory Compliance:

Ensure adherence to current Good Manufacturing Practices (cGMP), FDA regulations, and other applicable industry standards relevant to injectable products. Maintain up-to-date knowledge of regulatory changes affecting the injectable pharmaceutical industry.

Quality Assurance:

Develop, implement, and maintain compliance programs and quality management systems.

Lead investigations for non-compliance events, deviations, and product recalls, ensuring timely resolution and corrective actions.

Inspections and Audits:

Prepare for and conduct internal audits and inspections to assess compliance with corporate and regulatory policies.

Coordinate and manage external inspections (e.g., FDA, EMA) and respond to observations and findings.

Training and Development:

Develop and deliver training programs for staff on compliance policies, procedures, and best practices.

Foster a culture of quality and compliance throughout the plant.

Documentation and Reporting

Oversee the preparation and maintenance of Quality Systems documentation, including SOPs, change controls, and validation protocols.

Compile and report on compliance metrics and trends to management and relevant stakeholders.

Cross-Functional Collaboration:

Collaborate with production, engineering, and R&D teams to ensure compliance is integrated into all aspects of operations.

Act as a liaison between the plant and regulatory agencies, ensuring clear communication regarding compliance matters.

Continuous Improvement:

Identify areas for improvement in compliance processes and lead initiatives to enhance operational efficiency and safety.

Stay informed about industry best practices and integrate them into the plants compliance strategies.

Proven experience in quality assurance, compliance management, and auditing within a manufacturing environment.

Excellent organizational, analytical, and problem-solving skills.

Strong communication and interpersonal skills with the ability to collaborate effectively across departments.

Proficient in MS Office Suite and compliance management software.

Specific Skills and Experience:

• Knowledge of GMP, GLP, and other relevant regulatory guidelines.
• Experience in sterile manufacturing and aseptic processing.
• Proficiency in documentation management and record-keeping.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Experience in handling change control, deviations, and CAPA.
• Understanding of formulation development and process optimization

Preferred Skills:

Certification in quality management (e.g., ASQ, ISO) or relevant regulatory compliance.

Experience with risk management and mitigation strategies in a pharmaceutical context.

Familiarity with electronic documentation systems like Trackwise or equivalent.

Note:

Email : Harishwar.m@hetero.com ( Subject: Production Injectable Plant Compliance )

Cont: 8121005416 for further info.