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Wanted G.M. Quality (QA&QC) in pharma co.

Aditya Placement Associates
About Company

We are pleased to introduce ourselves as one of the premier recruitment agency specialized in the area of Information Technology catering our services to Foreign/Indian companies in India. We are a group of hardcore HR professional with experienced technical professionals, committed to their vision and objective to truly understand our clients’ business, the market in which they compete and their staffing needs and specifications.
Today APA is a known name in the corporate world, committed to offer aura of services in the area of skill outsourcing and development. Our consultants have in-depth market knowledge and maturity to handle search assignments with complete professionalism.
Operations of the company are directed from its office in New Delhi as well as from the Indian Silicon Valley, Bangalore. The company’s growth has been sustained through investments in the area of customer-satisfaction by working on regular feedback from our esteemed clients, thus resulting in quality and efficiency improvement.
Our main strength & specialization are in the areas of Information Technology, /Telecom Sector which accounts for more than 70% of our on-going assignments. We also have excellent expertise in healthcare, automobile, Petro Chemical, mechanical, Educational, finance sector consultancy.
The organization is managed along professional lines with emphasis on business planning, goal – oriented actions and accountability for both promises and performance in human resource management. It’s needless to say that Reliability; planning foresight and professionalism are norms at Aditya Placement Associates

Job Description

Position G.M. Quality (QA&QC) Vaccines

Educational qualification M.Sc (Micro biology, Biotechnology, Biochemistry, Pharmacy) preferably having Doctorate with minimum 12 to 17 years experience of leading a team of QA and QC of pharmaceutical sterile bulk and formulation facility.

Role & responsibility and KRAs:

8.1 To provide leadership in the development and continuous improvement of the documentation and data management processes site wide.

8.2 To lead the definition, development and implementation of the company’s Quality Management System in the delivery of Quality products and in accordance with ISO and FDA standards.

8.3 To manage team of QA Analysts in review, certification and release of product batches.

8.4 Review batch records to ensure that all steps have been performed and verified, that all limits and specifications have been met and that the raw materials have been tested and released.

8.5 Participate in the initial selection and qualification, implementation of necessary quality systems, and general quality oversight of biologics contract manufacturers.

8.6 Perform technical and quality reviews of contract and partner manufacturing sites and documentation related to the design, validation, operation and maintenance of biologics processes, equipment and facilities to ensure compliance with international cGMP regulations and standards.

8.7 Interact with contract manufacturers or partners, as well as other PBL departments to investigate and timely resolve quality and testing related issues and discrepancies.

8.8 Provide compliance oversight for clinical biologic drug product manufacturing and packaging, review of manufacturing/packaging batch records and analytical release testing data according to Standard Operating Procedures (SOPs) to ensure current Good Manufacturing Practices (cGMP) compliance, accuracy and completeness.

8.9 Manage the transfer of partner manufacturing processes to contract GMP manufacturers as well as technology transfer for new manufacturing projects.

8.10 To specifically manage Key Quality Management processes such as Management Review, Customer Complaint Handling, CAPA and Internal Audits and to manage all external audits of the company including Notified Body, FDA and Customer Audits.

8.11 Support regulatory agency submissions.

8.12 To identify and implement Continuous Improvement.

Critical Deliverables:

11.1 An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

11.2 Strong commitment to individual and team development with particular emphasis on delivery of Quality Training.

11.3 In ensuring that processes are established for capturing, documenting, communicating and measuring delivery against all customers requirements.

Timely completion projects
Experience: 12-18 yrs. expertise in:

14.1 Knowledge of current Good Manufacturing Practices, quality systems and quality assurance is required, along with working knowledge of manufacturing process steps and quality control for biologics product manufacturing, aseptic filling, utilities, and facilities.

14.2 Sound technical skills including working knowledge of biologics and pharmaceutical production, quality assurance, and testing technologies.

14.3 Experience complying with international regulatory standards.

14.4 Experience with contract operations and implementation of quality systems.

Ability to diplomatically enforce Quality expectations

Location Lalru (Near to Chandigarh)

Aditya Placement Associates
Ph 011 25088300,42730020
Hand Phone 011 64565555,09810174838
url : www.adityaplacement.com