General Manager - Quality Control

About the Company

A leading provider of CMO and R&D services to the top Indian & MNC pharmaceutical companies. The Acme Group began its journey in 2005 with a bold mission of becoming a leader in the contract manufacturing space and a preferred business partner for pharmaceutical companies seeking world-class capabilities and scalable operations. Guided by the founder's vision and purpose, the Acme Group has scaled new heights in the pharmaceutical value chain over the years. Today, it provides fully integrated contract manufacturing and development solutions to some of the top Indian and global pharmaceutical companies. Acme is driven by a belief in fast growth combined with a focus on innovation and service. The group currently consists of four state-of-the-art, fast-growing companies: Acme Formulation, Immacule Lifesciences, Acme Generics, and Veritas Research. Powering the group are 2,500+ highly skilled staff working across over 1 million sq. ft. of manufacturing space in Northern India. We produce 17 billion tablets, 3 billion capsules, 30 million liquid vials/ampoules, and 12 million lyophilized vials annually. Our expertise lies in the niche segments of oral hormones, including female sex hormones and levothyroxine, along with liquid and lyophilized injectables. We have expanded our sterile manufacturing capacity to produce an additional 60 million general liquid and lyophilized vials, 60 million liquid and lyophilized vials for oncology, 30 million three-piece ophthalmic containers, and 24 million pre-filled syringes and cartridges annually. Over the past decade, we have been audited and approved by various international regulatory agencies, including USFDA, UK-MHRA, EU-GMP, Health Canada, TGA Australia, ANVISA, INVIMA, and WHO Geneva. In addition, we have received approvals across major emerging markets in Asia, Africa, CIS, and Latin America. With 38 ANDAs approved, 18 ANDAs filed and under review, and a target of 50+ ANDA approvals by 2025, we continue our journey towards building a sustainable future as a leading CDMO.

Responsibilities

• Responsible for overall Quality control function of General block and Hormone block.
• To ensure the monitoring of RM, PM, In-process (Compression, Blend, Coating, and Filled Capsule), Bulk product, Finished Product, Stability, Micro and Process Validation samples analysis plan for their timely sampling, analysis and release.
• To ensure proper destruction of the left over sample.
• To ensure cGLP/ cGMP/ 21 CFR part 11 compliance in the laboratory.
• Co-ordination with R&D/outside labs from where product is transferred at site.
• Co-ordination with the customers for easy transfer of the projects.
• To approve the job description and assign the job to all QC team.
• To ensure that all the samples work sheets shall be controlled/ taken from LIMS.
• To Review of Finished product specifications, standard test procedures and work sheets in LIMS.
• To monitoring the samples to be sent to external labs for testing in which testing facility is not available.
• To coordinate with dispatch team and ensure to prioritize the analysis as per dispatch exigencies, and release the batches within stipulated time frame as per dispatch plan.
• To ensure the technical review, guidance and timely completion of Investigations e.g. OOS and OOT, Deviations, incidents and CAPA within stipulated time frame.
• To ensure the availability of current versions of the Specifications, Standard test procedures & work sheets are available in Documentation section.
• Drive continual improvement in business process/ operations with focus on business plan/ strategies.
• To identify the resources for QC function and ensure optimum utilization of resources.
• To review the risk assessment related to quality control.
• To impart the necessary trainings time to time to enhance the competencies and skill development.

Qualifications

Msc. / M. Pharma in Chemistry

Experience

20+ Years experience in QC and Min 5 years experience as Head QC