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QMS Coordinator

3 months ago

Bengaluru, Karnataka, India Syngene Full time

Designation: Asst. Manager

Job Location: Bangalore

Department: Formulation Quality Assurance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation .

Job Description:

Key Responsibilities:

Create/ revise procedures and other related documents as applicable. Review of SOPs, IOPs, EOPs, Protocol and Reports for Formulation Facilities. Handling of Change Controls, Deviations, CAPA, Customer complaints, Self-Inspection and Internal Quality Audit. Perform Trending of Change Controls, Deviations, CAPA, LIR and Customer complaints. Ensure compliance with observations of Self Inspection, Internal Quality Audit and client or regulatory audit. Perform activities related to SAP. Vendor qualification of raw material, packing material, consumables, contractors engaged in manufacturing pertaining to GMP manufacturing with respect to vendor questionnaire verification, vendor audit and compliance report verification for approval. Approval of vendors by desktop and site audits. (As required) Review of Risk assessment document from the vendor. Verification of vendor rating documents from the purchase. Inspection of RM, PM and consumables for any damage and discrepancy possible during receipt, storage dispensing and handling of these materials in warehouse. Review of vendor Quality Agreement. Preparation and updation of requalification schedule for Manufacturers. Archival of documents. Issuance of annexures and logbooks. Provide data for QMR and QGF meeting. Provide line clearance to Dispensing, Manufacturing and Packaging area. Provide dispatch clearance for Shipment. Preparation & Review of RSG report. Review and Approval of Calibration Certificate. Review of executed BMR and BPR. Responsible for review and release of Batches.

Educational Qualification: B. Pharm/ M. Pharm

Technical/functional Skills:

Candidate should have well versed with exposure in Oral Solid Dosage forms and injectable facility quality assurance activities. Candidate should have USFDA audit exposure. Establish good Interpersonal skills with cross-functional teams.

Experience: 9 Years + experience in Pharmaceutical industry.

Behavioural Skills:

Should have good communication skill and should be a good team player. Ability to work successfully in a dynamic, ambiguous environment. Ability to meet tight deadlines and prioritize workloads. Ability to develop new ideas and creative solutions. Should be a focused employee.

Leadership Capabilities:

• Proven ability to lead and motivate teams

• Excellent written and verbal communication skills

• Strong team player / works well in multi-discipline teams

• Good interpersonal skills, reads the needs and motivations of others to deliver high standards

• Builds strong plans to provide clarity for others, and utilizes time management tools and capabilities

• Analytical strengths and high trouble shooting ability

Leadership Competencies :

(for leading self, leading with others, and leading a team) Ability to understand the business, and role of different Enabling functions is important. Excellent interpersonal skills and demonstrated leadership abilities form the basic qualifications for this role.

• Partners with customer

• Provides clarity and focus - Drives performance against outcomes

• Drives accountability

• Works collaboratively

• Develops self and others

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.