Skills:
Pharmaceutical Production Formulation Specialist, Formulation Development, Quality Assurance, Regulatory Compliance, (cGMP), (ICH) guidelines,

Required - Pharmaceutical Production Formulation Specialist

Location: Ankleshwar, Gujarat, India

Industry- Pharma Formulation

Must have 3-5 Years of Experience (Must be from Formulation Industry)

Job Description

As a Pharmaceutical Production Formulation Specialist, you will play a pivotal role in the development and production of pharmaceutical formulations. Your responsibilities will encompass a range of tasks essential to the formulation process, ensuring the quality, safety, and efficacy of pharmaceutical products. This position requires a deep understanding of pharmaceutical sciences, formulation techniques, and regulatory requirements.

Key Responsibilities

Formulation Development: Lead the formulation development process for pharmaceutical products, including solid dosage forms (tablets, capsules), liquid dosage forms (syrups, suspensions), semi-solid dosage forms (creams, ointments), and sterile formulations (injectables). Collaborate with cross-functional teams to design and optimize formulations that meet target product profiles.

Process Optimization: Optimize formulation processes to improve efficiency, scalability, and product quality. Implement best practices and innovative technologies to enhance manufacturing processes and reduce production costs.

Quality Assurance: Ensure compliance with regulatory standards and quality control requirements throughout the formulation process. Conduct thorough quality assessments and perform in-process checks to maintain product consistency and adherence to specifications.

Documentation and Reporting: Maintain accurate documentation of formulation development activities, including formulation records, batch records, and technical reports. Prepare comprehensive reports summarizing formulation development activities, results, and recommendations for further action.

Troubleshooting and Problem Solving: Identify and resolve formulation-related issues that arise during production, ensuring minimal impact on manufacturing timelines and product quality. Implement corrective and preventive actions to address root causes of deviations and non-conformances.

Regulatory Compliance: Stay abreast of regulatory guidelines and requirements governing pharmaceutical formulation development and production. Ensure all formulation activities comply with current Good Manufacturing Practices (cGMP), International Conference on Harmonisation (ICH) guidelines, and other relevant regulatory standards.

Collaboration and Communication: Collaborate effectively with cross-functional teams, including R&D, regulatory affairs, quality assurance, and production, to align formulation activities with overall business objectives. Communicate effectively with stakeholders to provide updates on formulation development progress, challenges, and solutions.

Qualifications

Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field.

Proven experience in pharmaceutical formulation development, preferably in a manufacturing environment.

Strong understanding of pharmaceutical formulation principles, techniques, and technologies.

Knowledge of cGMP regulations, ICH guidelines, and other regulatory requirements applicable to pharmaceutical formulation.

Excellent problem-solving skills and attention to detail.

Effective communication and interpersonal skills, with the ability to collaborate across functional teams.

Ability to work independently and manage multiple projects simultaneously.

Proficiency in data analysis, documentation, and report writing.