Executive - CQA

Job Title:

Company:

Our GMP compliant, State of Art manufacturing facility for Tablet, Oral Dry Powder, Capsule, Nasal sprays, DPIs, Cream, Gel and Ointment formulations with dedicated manufacturing sections supported by In-House RD Center, focuses on Formulation and Analytical Development with an annual turnover of more than 200 crores and manpower of 500+ employees engaged across locations.

Job Location:

CTC to be offered:

Job Overview:

We are seeking a detail-oriented and organized Executive for our Corporate Quality Assurance (CQA) department to oversee the preparation, approval, and quality control of in-house and third-party manufacturing artworks. The ideal candidate will ensure compliance with regulatory standards, coordinate with various departments, and maintain accurate documentation throughout the process.

Key Responsibilities:

Preparation Approval of In-house Artworks:

• Review and compile Artwork Information Form (AWIF) for artwork development (Domestic/Export commercial/Registration dossier/Domestic tender).
• Coordinate with Medical department for leaflet requirements and updates.
• Conduct initial review of developed artwork.
• Obtain necessary approvals from Marketing, Medical, DRA, Plant, PMT, and other relevant departments.
• Follow up with Marketing for customer approval on foreign language artworks.
• Final review and approval of artwork for CDR file release.
• Coordinate with the purchase department for printers PDF approval.

Preparation Approval of Third-Party Manufacturing Artworks:

• Review and compile AWIF for third-party manufacturing artworks.
• Liaise with Contract Manufacturing Division (CMD) for mock-up size requirements.
• Coordinate with Medical for leaflet needs.
• Conduct initial artwork review.
• Obtain necessary approvals from Marketing, Medical, DRA, Plant, PMT, TPM, and other relevant departments.
• Coordinate customer approval process for foreign language artworks.
• Final review and approval of artwork for CDR file release.
• Manage shade card approvals and maintain artwork status.

Batch Releases for Third-Party Manufacturing Products:

• Conduct pre-dispatch inspections for third-party manufacturing products.
• Perform visual inspections of received samples.
• Review certificates of analysis and FP reports.
• Coordinate with TPM for sample or report discrepancies.
• Prepare and review certificates of analysis when applicable.
• Coordinate with logistics for certificate of analysis for batch release.
• Maintain data for third-party release and manufacturing products.
• Manage TPM-related reports and compliance documents.

Handling of Market Complaints for Third-Party Manufacturing Unit:

• Record and document complaints received from marketing.
• Coordinate with manufacturing plants for investigation reports.
• Review and compile investigation reports for resolution.

Qualifications and Skills:

• Bachelors degree in Pharmacy, Chemistry, or related field.
• Proven experience in artwork approval and quality assurance processes.
• Strong knowledge of regulatory requirements for pharmaceutical products.
• Excellent communication and coordination skills.
• Ability to work effectively in a cross-functional team environment.
• Detail-oriented with strong organizational and documentation skills.
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