Senior Officer - Documentation

Job Description:

Responsibilities

• Initiate Master Manufacturing Records (MMaRs) & Master Packaging Record (MPaRs)
• Initiate Placebo and Optimization batch record for trails.
• Initiate Change Controls in QMS Track Wise for New Launch / Site Transfer / Submission batch / SOPs / Formats and commercial batch documents.
• Ensure QMS Change control closure within the stipulated timeline.
• Ensure support for timely completion of Investigations for document related deviations and document revision based on CAPA.
• Initiation of batch documents , SOPs and Formats in Content server.
• Check Monthly Schedule to ensure document readiness.
• Ensure all changes are aligned with cGMP regulations and corporate SODs.
• Perform all work in accordance with established regulatory, compliance and safety requirements.
• Coordinate with NPL and RA regarding Deficencies from Regulatory Agencies and Clarifix.
• Develop and maintain effective working relationships with internal and external customers.

Qualification & Experience

• Minimum Bachelor of Pharmacy / Science or any equivalent degree.
• Experience
• Minimum 1 year of experience in GMP regulated pharmaceutical industry.
•  Knowledge, Skills and Abilities
• Adequate knowledge in handling QMS Trackwise tool, Content server tool.
• People management skillset
• Adherence to cGMP
• Exhibit Perseverance in all the tasks performed
• Problem solving skills