Established in 1973 and headquartered in Mumbai, India, Alkem began operations as a health care marketing company. Alkem has since grown to become India’s seventh largest pharmaceutical company with sales revenues exceeding USD 500 million with a CAGR of 16% over the last five years.
Alkem, one of the India’s leading generic and specialty pharmaceutical companies, is a significant player in the branded drugs and generic drugs space. With a wide ranging presence across acute and chronic therapeutic segments with substantial brand share in the Central Nervous System, Gastro-intestinal, Anti-diabetic, Anti-osteoporosis, Anti-malarial, Cardiovascular, Immunosuppressants, and Nutraceutical segments, Alkem leads the Indian market in the Anti-infective and Pain Management segments.
Experience: 15-20 years
Industry Type: Pharma/ Biotech
Functional Area: QA/QC
End Date: 15th November, 2015
Post: Head of Quality (QA/QC)- Daman
Educational Qualification - M.Pharm
- 15 to 20 years of experience out of which atleast one year experience as Head Site Quality.
- Having faced and successfully cleared regulatory audits such as USFDA, MHRA, TGA, EUGMP, etc.
- The role requires a person who has driven and assertion.
- Ability to communicate and negotiate with others in a logical manner.
- A friendly approach and the ability to influence and persuade others, including those outside immediate sphere of influence at peer level.
- A self-starter, healthily competitive, imaginative, enthusiastic, self-confident, inspiring, systematic and precise individual.
- Should be practical; people oriented, go getter, process orientated & result oriented.
- Functioning as Head - Quality based at Amaliya Site and will be responsible for Quality activities at Amaliya (Including B Block) and Kachigam Plant.
- Accountable for the online compliance and readiness of site to various external inspections ensuring adherence to cGMP standards of all applicable regulatory / customer standards and expectations and meeting to continuous improvement in system, practices and documentation.
- Accountable for implementation, execution and monitoring of all Quality objectives and goals at Alkem, Daman location. In this process to lead all the site efforts on simplification, Harmonization, systems, procedures, documentation, enhancement of current systems and procedure through effective globally compliant CAPAs to ensure continuous cGMP improvements of all QMS and operations bearing an impact on Quality safety and efficacy of product and processes.
The key responsibility to meet above goals includes:
1. cGMP Compliance at Site
Responsible for implementation and monitoring of cGMP at site(s) through Quality Management Systems governance to ensure its suitability and effectiveness
2. Quality Assurance & Quality Control Compliance
Responsible for activities of Quality Assurance and Quality Control functions and its compliance to established standards and procedures through review and approval of quality documents generated at QA & QC.
3. Implementation of CQA Procedures
Responsible for review and effective implementation of Procedures and Guidance Documents at site issued from Corporate Quality Assurance. Responsible to provide support in the harmonization of Quality Systems/Guidance documents at site. To review and report the performance of Quality Management system and any need for improvement.
4. Interaction with CFT
Responsible to communicate with the cross functional team members such as Business development, SCM, Operations, Engineering, R&D, DRA, commercials and other relevant site/ corporate functions; timely, on the Quality matters.
5. Support in Regulatory Submissions
Responsible for providing all product documents required for preparation of dossiers and submission to regulatory authorities through DRA. Responsible for timely compliance to the queries/ deficiencies noted by various regulatory agencies.
6. Mentoring and Training to Site Personnel
To identify and propose the value addition requirements and need of site Quality Team and other operational areas for enabling their efficiency and knowledge levels by facilitating the training/ knowledge sharing sessions from time to time.
To review the effectiveness of routine training program conducted at site and guide site personnel to perform their role to achieve Quality objectives.
7. Escalation of Events & Quality Concern to CQA
Responsible for escalating reported events, incidents, like to like procedural deviations having an impact on product Quality and Safety as identified under management notification procedure to Corporate Quality Head. To track the effective remediation in consultation with Corporate Quality Head and Site Operation in all such identified, escalated management notification and will review and monitor recurrence of similar events and plan remediation in consultation with Head CQA.