Job Title: Executive - Corporate Quality Assurance
Company: SAVA Healthcare is amongst the fastest emerging pharmaceutical company in India with global reach to customers in Canada, Ukraine and the CIS, Asia, Latin America, Africa & FWA. With manufacturing units in Surendranagar, Malur and in near future in Indore holds various accreditations and produces wide variety of dosage forms across therapeutic categories.
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 R&D 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: Corporate Office, Viman Nagar, Pune
CTC to be offered: 4 LPA to 6 LPA
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 printer's 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:
- Bachelor's 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.
