Job Description

The Manager- QA/AC plays a critical role in the development and launch of new pharmaceutical products within the organization. This position requires a detail-oriented individual with a strong understanding of GMP practices, Quality, and legal compliances, and pharma regulations. The Manager QA/QC will collaborate with cross-functional teams and internal and external stakeholders, coordinate project activities, and ensure adherence to timelines and quality standards, and compliances for new product development in the organization.

Responsibilities:

1. Evaluate the various manufacturing facilities by conducting the facility GMP audits/inspections as per regulatory guidelines and approve the facility post proper due diligence and publish an audit report for compliance if required.

2. Evaluate the tech pack (Quality documents/dossier) of the shortlisted finished formulations across various dosage forms manufactured by the manufacturer to ensure the pre-requisite quality requirements to approve the product.

3. Development of the finished formulations with the same standard as the Innovator in terms of bioequivalence and therapeutic equivalence,

4. Ensure the compliance of pharmaceutical jurisprudence i.e. acts and rules for the new products like Drugs and Cosmetics Acts and rules, DPCO Act, NDPS Act and Drugs and Magic Remedies (Objectionable Advertisement) Act, etc.

5. Ensure regulatory and legal compliance for new product launches.

6. Handle contract manufacturing Facilities by carrying out their periodic Facility and Product Audits and timely revert to the Manufacturing Vendors on Audit findings and closures.

7. Identify Non-Conformances and work towards closure with RCA and CAPA,

8. Review and approve the quality documents received from the contract manufacturer relating to manufacturing new batches and ensure necessary regulatory and quality Compliance

9. Ensure Internal Quality reports reviews on a monthly basis and share the findings with the respective stakeholders and perform CAPA if required

10. Coordination with Contract/Public Testing Labs to ensure the products are being tested at regular intervals in order to ensure the product quality

11. Ensure liaison between local/state FDA and CDSCO in case of NSQ or any query received from the regulatory body

12. Log and investigate market complaints with customers and manufacturing sites, for RCA and closure with appropriate CAPA

13. Keep track of near-patent expiry products and initiate the development of formulations with contract manufacturers and ensure the launch of products as and when the patent expires

14. Keep track of new innovative drug products and their combinations approved by DCGI in India,

15. Keep track of products that are in the development stage with contract manufacturers.

16. Manage / Implement corporate quality management system through SOPs, and documentation throughout contract manufacturing sites

Desired Skills and Expertise:

- An expert in the understanding of manufacturing stages and critical processing stages of Oral Solid Dosage Form, Oral Liquid Dosage Form & Injectables / Parenteral, and various other dosage forms

- Good knowledge and assessment capabilities of manufacturing sites with respect to GMP and GLP

- Experience in working with Contract testing Laboratories for product quality testing

- Experience in Auditing WHO, EU GMP, or USFDA-certified Facilities

- Good understanding of Pharmacopoeia, WHO - GMP, Schedule M & ICH Guidelines

- Good understanding of the Drug and Cosmetic Act from regulatory and artwork Management standpoint.

- Good understanding of market leaders/brands in respective compositions and therapeutic classes and categories.

- Good knowledge of investigation tools for RCA and CAPA.

- Understanding of vendor management (Product and Facility Audit)

- Good written and verbal communication skills

- Self-driven and motivated

- Willing to work in a fast pace, challenging environment in a Start-up

- Hands-on experience with Excel.

Qualifications Required:

- Degree in pharmaceutical sciences or pharmacy.

- Minimum 5 years of experience in Corporate Quality Functions including experience in site auditing and compliance.

- Minimum 1 year of experience on the manufacturing floor.

IIM Jobs